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Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.The Manager for the QA Sterility Assurance group is an individual contributor responsible for quality oversight of the site contamination control strategy, including Environmental Monitoring (EM).&nbsp; Duties/Responsibilities include, but not limited to:<ul><li>Quality oversight and support for contamination control programs such as environmental monitoring, cleaning and disinfection, gowning, access and flow, facility modifications, qualifications, disruptions, and shutdowns.&nbsp;</li><li>Quality oversight and support for Microbiology QC Testing Methods.&nbsp; Review and approve associated document revisions, protocols, reports, testing plans,</li><li>Review and approve investigations/ CAPAs / effectiveness checks associated with the manufacturing site including but not limited to environmental monitoring excursions (EME), aseptic personnel qualification (APQ), aseptic operations, cleanrooms, utilities, and Microbiology laboratory.</li><li>Quality Oversight and Management of Environmental Monitoring Trending Program.&nbsp; Author or Review and approve EM and Utility trending reports at designated frequencies (i.e., quarterly, and annually).&nbsp;</li><li>Review and approve qualification lifecycle documentation associated with manufacturing cleanrooms, water and gas utilities, including but not limited to environmental monitoring process qualification (EMPQ), aseptic process simulation (APS), airflow visualization (AVS), cleanroom reclassification (CRC),</li><li>Creation and Revision of technical documents (SOPs, Risk Assessments, Reports, Protocols, etc.).&nbsp; Quality Approvals of documents created by others.&nbsp;</li><li>Quality oversight and approvals for disruptions and shutdowns to the cleanroom environment.</li><li>Facilitate and/or approve quality risk assessments and technical reports associated with the contamination control strategy (CCS), including but not limited to disinfectant efficacy testing (DET), drug product process and facility microbial risk assessments).</li><li>Review and approve or provide impact assessment for site change controls. Author impact assessments for complex level site change controls and EMPQ assessments.&nbsp;</li><li>Supports the Contamination Control Strategy, Quality Initiatives, and Identify continuous improvement opportunities.&nbsp; Supports execution of site/team improvement goals and projects related to environmental and contamination control programs.&nbsp; &nbsp;Perform associated quality approvals as required.&nbsp;</li><li>Routinely recognize and resolve Quality issues; propose solutions for complex issues and work with management to resolve.</li><li>Support internal and external inspections as required. Participate in the preparation and execution of corrective and preventative actions related to inspection findings. Perform associated quality approvals as required.</li><li>Maintain compliance with assigned learning plan. Support development of training content.</li><li>Act as Subject Matter Expert and provide guidance/ coaching to less experienced staff with atypical microbial events.</li><li>Lead meetings and represent function at cross functional and network meetings. Share data/ knowledge within team, and across site and network.</li><li>Ability to collaborate with cross-functional team members on projects related to contamination control program. Build and maintain strong relationships with partner departments.&nbsp;</li><li>Perform other tasks as assigned.&nbsp;</li></ul><ul><li>This position reports to the Associate Director of Quality Assurance Sterility Assurance at Cell Therapy Manufacturing: Bothell.</li></ul>Specific Knowledge, Skills, Abilities: <ul><li>Excellent verbal and technical writing skills with advanced ability to prepare written communications and present complex technical data to management with clarity and accuracy.</li><li>Ability to research, understand, interpret, and apply internal policies and regulatory guidelines.</li><li>Demonstrated experience with interpreting complex data, results, and problems with multiple variables and critically assess and provide feedback on proposed solution and required documentation.</li><li>Demonstrated experience to critically review investigation reports, interpret results, and assess and challenge technical conclusions consistent with Quality risk management principles.</li><li>Ability to work in a fast-paced team environment and lead peers through changing priorities.</li><li>Ability to think strategically, meet deadlines and support work prioritization.</li><li>Able to independently work across functional groups and teams to ensure requirements are met.</li><li>Self-motivated and ability to motivate and foster a positive team environment.</li><li>Confident in making decisions, able to anticipate Quality issues and proactively solve problems.</li><li>Curious with ability to think critically to create innovative solutions.</li><li>Proficient computer skills with knowledge of several digital tools like MS Office, etc., and ability to learn and work with new software applications.</li></ul>Education/Experience/ Licenses/Certifications:<ul><li>Bachelor's Degree in Microbiology, Biology, STEM, or related science.</li><li>6+ years of relevant cGMP experience or equivalent combination of education and experience in a regulated industry, preferably with 2+ &nbsp;years of Quality assurance experience.&nbsp;</li><li>Experience in Quality Control or Quality Assurance function in a cGMP manufacturing operation. Experience with Aseptic Processes and Practices, Contamination Control, Risk Management, and Quality Systems.</li><li>Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing.&nbsp;</li><li>Demonstrated ability to collaborate and lead cross-functionally to develop and maintain strong business partner relationships.</li><li>Demonstrated experience with electronic systems and databases.&nbsp;</li><li>Demonstrated experience with root cause analysis and risk management tools such as 5-WHY, Human Error Prevention, Fishbone Analysis, FMEA, PrHA, etc.</li><li>Demonstrated experience with electronic document and validation documentation systems.</li></ul>If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Compensation Overview:Bothell - WA - US: $103,300 - $125,176&amp;#xa;The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.&nbsp; Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit <a href="https://careers.bms.com/life-at-bms/" target="_blank">https://careers.bms.com/life-at-bms/</a>. Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.On-site ProtocolBMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to <a href="mailto:adastaffingsupport@bms.com" target="_blank">adastaffingsupport@bms.com</a>. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:&nbsp;<a href="https://careers.bms.com/california-residents/" target="_blank">https://careers.bms.com/california-residents/</a>Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Bristol Myers Squibb

Manager - QA Sterility Assurance

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.This is a key role on the Shop Floor Quality Assurance team. As Manager, Shop Floor Quality Assurance, Cell Therapy, you will lead a team of 4-8 employees.&nbsp; &nbsp;The Shop Floor Quality Assurance team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, and Warehouse Operations.This position will oversee and partner with operational teams to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP.The Manager, Shop Floor Quality Assurance, Cell Therapy is responsible for quality activities for the Cell Therapy Facility in accordance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP.&nbsp; Functional responsibilities include ensuring operational compliance with applicable procedures and batch records, providing real time review of manufacturing batch record documentation and logbooks, and working with operations to resolve manufacturing issues.&nbsp;The Manager, Shop Floor Quality Assurance role is stationed in Devens, MA and reports to the Senior Manager, Field Quality Assurance for the Devens CTF.Shifts Available:6am – 6pm, rotating schedule including holidays and weekends, onsiteResponsibilities:<ul><li>Provide leadership to ensure routine on-the-floor Quality oversight and to ensure collaborative triages of unexpected events within the Manufacturing, Quality Labs, and Supply Chain operational areas and systems. </li><li>Have a comprehensive understanding of Cell Therapy processes to enable real-time decision-making.</li><li>Advanced ability to synthesis information from multiple sources, interpret problems and effectively communicate to cross-functional management in a clear, brief, and accurate manner. </li><li>Respond to complex/critical issues and build a consensus of understanding with subject-matter experts for product impact and justification to continue manufacturing. </li><li>Serve as a subject matter expert supporting others to navigate the BMS quality management system including but not limited to deviation and CAPA action management, interim production controls, disposition decisions, and batch record management.&nbsp; </li><li>Provide direction and timely guidance to QA shift-managers regarding the handling and resolution of cGMP events which may be a part of deviations, batch record exceptions, and other quality operational issues. </li><li>Accountable for the performance/delivery of the QA field quality organization, including oversight of the “QA on-the-floor” systems and programs that enable the highest quality and the quickest delivery of QA cGMP tasks. </li><li>Develop and implement standard-work for team-members that balances on-floor support for non-routine events, routine quality assurance work, and stretch/development project-work. </li><li>Champion a culture that embraces psychological and physical safety of employees in the work environment.</li><li>Champion a culture of teamwork, communication, and continuous improvement focused on defining problem statements, driving initial investigative efforts, and actioning solutions to reduce recurrence. </li><li>Proactively identify and address quality risks and critical issues, drive mitigations with the aid of Field Quality Staff and cross-functional partners and escalate to senior management as needed.</li><li>Lead walkthroughs with peers or QA team-members to identify and remediate operational or quality issues. </li><li>Review and interpret the technical conclusions of a record/investigation and provide constructive feedback.</li><li>Independently approve deviation records within the quality management system consistent with quality risk management principles and in accordance with process knowledge</li><li>Regularly spend time coaching and mentoring operators and Field QA specialists while on the manufacturing floor.</li><li>Interview, hire, coach, motivate, and develop exceptional staff. Set performance objectives and development plans. Monitor performance progress and conduct performance reviews for all direct reports.</li></ul>Knowledge and Skills:<ul><li>Ability to lead an on-site quality operations teams working a 6am to 6pm shift on a rotating 2-3-2 Panama schedule.&nbsp;</li><li>Demonstrated experience with quality management systems for handling of records such as change control, product complaints, deviations, investigations, and CAPA management.</li><li>Experience working in aseptic/sterile environments and/or in quality control operations focused on microbial controls and contamination mitigation strategies is preferred.&nbsp;</li><li>Ability to research, understand, interpret, and apply internal policies and regulatory guidelines</li><li>Proficient computer skills with knowledge of several digital tools like MS Office, etc., and ability to learn and work with new software applications.</li><li>Advanced ability to interpret data &amp; results, understand complex problems with multiple variables, and articulate practical&nbsp; solutions.</li><li>Excellent written and verbal skills and advanced ability to present technical data effectively based on target audience</li><li>Ability to work in a fast-paced team environment and lead peers through changing priorities</li><li>Ability to think strategically, meet deadlines, and support work prioritization</li><li>Ability to negotiate and influence to craft mutually beneficial solutions</li><li>Ability to motivate and foster a positive team environment&nbsp;</li><li>Exhibit strong decision-making and ability to think creatively while maintaining compliance and quality</li><li>Pioneering mindset and ability to create innovative solutions</li><li>Ability to think strategically, with an enterprise-mindset, establish deadlines and prioritize work according to the needs of the business and within budget.</li><li>Ability to research, understand, interpret, and apply internal policies, cGMP, and quality principles.</li><li>Establishment of strategic goals, departmental objectives, and motivating team to achieve operational tasks.</li><li>Exhibits strong decision-making ability and analytical thinking while maintaining compliance and quality.</li><li>Proactively finds solutions to quality and operational problems by creative thinking and innovative solutions.</li><li>Proven ability to negotiate mutually beneficial solutions and resolve differing perspectives among stakeholders.</li><li>Ability to understand complex problems with multiple datum/variables and articulate practical solutions.</li><li>Excellent technical writing/verbal skills. Ability to effectively present technical data based on target audience.</li><li>Demonstrated experience working with GxP electronic systems such as Manufacturing Execution Systems (MES) for electronic batch records; Enterprise Resource Planning (ERP) such as SAP; laboratory information management systems; or Quality Management Systems such as TrackWise or Veeva.</li><li>Ability to lead change in a fast-paced environment with limited information and/or time-constraints.</li><li>Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is required.</li><li>Experience with microbial controls, lean or six-sigma improvements, or as a technical/scientific process engineer in the biopharmaceutical industry preferred.</li></ul>Basic Requirements:<ul><li>Bachelor's degree in STEM field preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered.</li><li>6+ years of relevant cGMP experience, preferably with 2+&nbsp; year of QA shop floor experience.</li><li>Ability to work within pharmaceutical cleanroom environments.</li></ul>Working Conditions:PHYSICAL /MENTAL DEMANDS:&nbsp; <ul><li>Able to work near strong magnetic fields.</li><li>Able to gown for ISO 8 and ISO 7 rooms (medical scrubs, safety shoes, safety glasses, gloves, etc.).</li></ul>BMSCART#LI-ONSITEGPS_2025If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Compensation Overview:Devens - MA - US: $100,480 - $121,756&amp;#xa;The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.&nbsp; Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit <a href="https://careers.bms.com/life-at-bms/" target="_blank">https://careers.bms.com/life-at-bms/</a>. Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.On-site ProtocolBMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to <a href="mailto:adastaffingsupport@bms.com" target="_blank">adastaffingsupport@bms.com</a>. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:&nbsp;<a href="https://careers.bms.com/california-residents/" target="_blank">https://careers.bms.com/california-residents/</a>Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Manager, Shop Floor Quality Assurance, Cell Therapy in Devens, MA

Job description Our purpose – Opening up a world of opportunity – explains why we exist. Here at HSBC we use our unique expertise, capabilities, breadth and perspectives to open up new kinds of opportunity for our more than 40 million customers. We’re bringing together the people, ideas and capital that nurture progress and growth, helping to create a better world – for our customers, our people, our investors, our communities and the planet we all shareThis is performed through a thorough and comprehensive evaluation and/or assessment of the audit activities and related documentation, utilizing IIA Standards, internal methodology, any local regulations, and internal procedures and processes. &nbsp;In addition, the QA Function is responsible to provide for insight into the overall adherence to Internal Audit individual responsibilities and independence such skills assessments, reporting of conflicts of interest, and the like, as well as local regulatory mandates and requirements. &nbsp;Results of evaluations and assessments can by analyzed and lessons learned can be embedded into audit methodology, working practices, behaviors, reporting, and Internal Audits learning programmeAs our Quality Assurance - Senior Audit Manager, Professional Practices you will:<ul><li>Assist in the development of the Quality Assurance and Improvement Program and manage the successful completion of the plan</li><li>Deliver Quality Assurance Reviews in accordance with the Institute of Internal Auditors (IIA) Standards and best practices</li><li>Deliver other assigned Quality assurance related reviews and activities (for example, Audit Effectiveness, Thematic and Framework) as per the </li><li>Quality Assurance and Improvement Program Framework&nbsp;</li><li>Identify audit process improvements to increase productivity, efficiency and effectiveness</li><li>Assist in the development and delivery of appropriate global training programs to various levels of management and staff within Internal Audit, to ensure knowledge and skills are appropriate across Internal Audit</li><li>Establish effective, credible and appropriate working relationships with all Internal Audit colleagues</li></ul>For this role, HSBC targets a pay range between $134,500.00 and $201,800.00.The final fixed pay offer will depend on the candidate and a number of variables, including but not limited to, role responsibilities, skill set, depth of experience and education, licensing/certification requirements, internal relativity, and specific work location.At HSBC, our overall goal is to provide a competitive Total Reward Package, with an appropriate mix of fixed pay, and variable pay, as part of an employee’s overall total compensation and benefits. Variable pay generally takes the form of discretionary, annual awards (sometimes referred to as a “bonus”). Additionally, HSBC offers a wide range of competitive and flexible benefits designed to help you improve your health and well-being, finances, and lifestyle. Requirements You´ll likely have the following qualifications to succeed in this role:<ul><li>Minimum of ten years proven and progressive audit, business, and/or accounting experience or equivalent</li><li>Minimum of a bachelor’s degree in business, accounting, finance, related field or equivalent experience</li><li>Fluent in Spanish preferred but not required&nbsp;</li><li>Strong managerial skills, written and verbal communication skills, analytical, problem-solving, organizational, lateral thinking and interpersonal skills</li><li>Strong stakeholder management skills to effectively challenge senior management while maintaining professional and repeatable relationships</li><li>Broad knowledge of the Company, Group and financial services industry, business supported and the regulatory framework they operate in</li><li>Ability to apply technology or expertise to business issues or operational problems</li><li>Professional certification (s) preferred</li></ul>In compliance with applicable laws, HSBC is committed to employing only those who are authorized to work in the U.S. Applicants must be legally authorized to work in the U.S. as HSBC will not engage in immigration sponsorship for this position.As an HSBC employee, you will have access to tailored professional development opportunities to ensure you have the right skills for today and tomorrow. We offer a competitive pay and benefits package including a robust Wellness Hub, all in a welcoming, diverse and inclusive work environment. You will be empowered to drive HSBC’s engagement with the communities we serve through an industry-leading volunteerism policy, a generous matching gift program, and a comprehensive program of immersive Sustainability and Climate Change Initiatives. You’ll want to join our Employee Resource Groups as they play a central part in life at HSBC, including the development of our employees and networking inside and outside of HSBC. We value difference. We succeed together. We take responsibility. We get it done. And we want you to help us build the bank of the future!All qualified applicants will receive consideration for employment without regard to age, ancestry, color, race, national origin, ethnicity, disability or medical condition, genetic information, military or veteran service, religion, creed, sex, gender, pregnancy, childbirth, caregiver status, marital status, citizenship or immigration status, sexual orientation, gender identity or expression or any other trait protected by applicable law

HSBC

Quality Assurance - Senior Audit Manager, Professional Practices

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.SummaryThe Senior Specialist, External Manufacturing Quality Assurance is responsible for quality oversight of the Contract Manufacturing Organization (CMO) operations for Radiopharmaceutical products in accordance with business agreements, regulatory standards, and RayzeBio procedures.&nbsp; The scope includes clinical and commercial products as well as Standard of Care products, in accordance with RayzeBio policies, standards, procedures and global current Good Manufacturing Practice (cGMP).The Senior Specialist provides Quality support and oversight for CMO operations and disposition activities including review and approval of Deviations, CAPAs, Change Controls, documents, Batch Records, and Lot Disposition.&nbsp; This person will also interact with the Qualified Person (QP) as needed to facilitate release of EU doses.&nbsp;Job ResponsibilitiesEssential duties and responsibilities include the following. Other duties may be assigned.<ul><li>Support Quality disposition process by ensuring that all required documents are accurately and properly completed and compiled against approved procedures and specifications, including all related deviations.&nbsp;&nbsp;</li><li>Develops and implements policies and procedures for CMO compliance, including development of applicable Quality Agreements, Quality Business Processes, Product Disposition, and Quality Event Resolution in accordance with organizational strategy and business realities.&nbsp;&nbsp;</li><li>Ensures approved quality systems are established and maintained to RayzeBio’s quality standards and regulatory requirements.&nbsp;&nbsp;</li><li>Partner closely with CMOs and RayzeBio’s leadership team to ensure consistent and collaborative messaging to external manufacturing partners.</li><li>Work cross functionally to provide a single point of contact for QA technical support to internal teams and external manufacturing partners. Provide communication, support, and guidance to manufacturing partners and within the QA team. Effectively communicatee issues, risks and proposed solutions within the organization.&nbsp;&nbsp;</li><li>Assist with and provide QA approval of investigations, CAPAs, change controls, validation documentation, and other related GMP documentation related to Externally Manufactured product.&nbsp;&nbsp;</li><li>·Identify and report discrepancies from required work practices or procedures to management.&nbsp;</li><li>·Make sound decisions by exercising judgment within generally defined practices and policies and applies appropriate notification to management as appropriate.&nbsp;</li><li>·Participate as requested in the response team for audits and inspections by health authorities.&nbsp;</li></ul>Education and Experience<ul><li>BS/MS degree in science related field (including biology, biochemistry, chemistry, engineering, or related areas) is preferred</li><li>Minimum of 5 years’ experience in quality assurance and/or compliance roles in the pharmaceutical industry.</li><li>Hands-on experience with QA oversight of contract manufacturing organizations is highly desired, but applicable Quality experience will be considered&nbsp;&nbsp;</li></ul>Skills and Qualifications<ul><li>Expertise in GMP, Quality, material and product disposition </li><li>Strong capability in authoring and critically reviewing investigations, interpreting results, and generating technical conclusions consistent with Quality risk management principles </li><li>Detail-oriented with demonstrated applications in problem solving and decision-making abilities with moderate oversight from management&nbsp; </li><li>Strong project management skills and organizational ability to follow projects through to completion&nbsp;&nbsp;&nbsp; </li><li>Team player who can work independently to achieve objectives in a fast-paced environment </li><li>Excellent verbal and written communication skills.&nbsp; </li><li>Audit and inspection management experience.&nbsp; </li><li>Strong background and demonstrated effectiveness in quality assurance operation and compliance of clinical/commercial manufacturing is desired.&nbsp;</li><li>Knowledge of US, EU and rest-of-world cGMP regulations and guidance.&nbsp;</li><li>Knowledge and proven experience in FDA, EMA, or other regulatory authority.&nbsp;</li><li>Demonstrated leadership, interpersonal, communication, and motivation skills.&nbsp;</li><li>Previous work responsibility, which required a high degree of attention to detail.&nbsp;</li><li>Well-practiced in exercising sound judgment in decision-making.&nbsp;</li><li>Demonstrated prioritization and organization skills.&nbsp;</li></ul>Physical DemandsWhile performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 30 pounds. Specific vision abilities required by this job include close vision and distance vision.  Work EnvironmentThe noise level in the work environment is usually moderate.&nbsp; &nbsp;This position may require &nbsp;work outside of normal working hours or on weekends.&nbsp; #RayzeBio, GPS_2025, #LI-OnsiteIf you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Compensation Overview:Indianapolis - RayzeBio - IN: $82,236 - $99,650&amp;#xa;The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.&nbsp; Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit <a href="https://careers.bms.com/life-at-bms/" target="_blank">https://careers.bms.com/life-at-bms/</a>. Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.On-site ProtocolBMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to <a href="mailto:adastaffingsupport@bms.com" target="_blank">adastaffingsupport@bms.com</a>. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:&nbsp;<a href="https://careers.bms.com/california-residents/" target="_blank">https://careers.bms.com/california-residents/</a>Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Sr. Specialist, External Manufacturing Quality Assurance

Castle Biosciences Earns a Top Workplaces USA Award for the Fourth Consecutive Year!You won't find a work culture and benefits package like ours every day. Come join our team and a group of colleagues who love working at Castle!Learn more at <a href="http://www.CastleBiosciences.com" target="_blank">www.CastleBiosciences.com</a>Castle Biosciences Inc. is growing, and we are looking to hire a Molecular Quality Assurance Technologist working from our laboratory in Phoenix, AZ location.Why Castle Biosciences?Exceptional Benefits Package:<ul><li>Excellent Annual Salary + 20% Bonus Potential</li><li>20 Accrued PTO Days Annually</li><li>10 Paid Holidays</li><li>401K with 100% Company Match up to 6%</li><li>3 Health Care Plan Options + Company HSA Contribution</li><li>Company Stock Grant Upon Hire</li></ul>A DAY IN THE LIFE OF A Laboratory, Molecular Quality Assurance Technologist,The Molecular Quality Assurance Technologist supports Castle's Quality Management System by ensuring data integrity, regulatory compliance, and accurate documentation across the Laboratory, Compliance, Clinical, Research, IT, and Clinical Services departments. This role involves maintaining Key Performance Indicators and trackers, preparing data reports, assisting with audits, and managing regulatory and compliance records, including CAP, CLIA, FDA, and NY State requirements. The QA Technologist also supports the document control system by managing QMS materials, SOPs, assigning and tracking training modules, and assisting with workflow implementation. Additional responsibilities include supporting regulatory submissions, facilitating interdepartmental communication, and coordinating materials for meetings and trainings. Most of the role is dedicated to quality assurance activities that maintain laboratory assay and device compliance, including reviewing QMS documentation, managing regulatory records, supporting audits, and collaborating with teams to ensure consistent quality practices and continuous improvement.REQUIRED QUALIFICATIONS<ul><li>Bachelor's Degree or MLT (AA) in scientific, engineering, or mathematical discipline or equivalent</li><li>Solid understanding of clinical lab methodologies &amp; general regulatory requirements such as, HIPAA, Good Clinical Practice, FDA, CAP, CLIA, CLEP NY state regulations.</li></ul>PREFERRED QUALIFICATIONS<ul><li>2-4 years' experience with data/IT in a research or clinical lab and/or development/manufacturing environment, preferred.</li><li>Knowledge of computers, spreadsheets, and databases for data management, analysis, &amp; working with pivot tables/graphs, &amp; IT, experience preferred. </li><li>Clinical Quality Assurance &amp; Quality Management experience (preferred)</li></ul>*Please see the full success profile (job description) at the end of the job ad.SCHEDULE<ul><li>Monday-Friday, from 8:30 AM-5:00 PM, exempt position, working from the Phoenix, AZ laboratory.</li></ul>READY TO JOIN OUR BIOTECH TEAM?We understand your time is valuable, and that is why we have a very quick and easy application process. If you feel that this would be the right position for you, please fill out our initial 3-minute, mobile-friendly application. We look forward to meeting you!WORK AUTHORIZATIONAll candidates must be legally authorized to work in the United States. Currently, Castle Biosciences does not sponsor H1B visas, OPT, or other employment-related visa's. WORK AUTHORIZATIONAll candidates must be legally authorized to work in the United States. Currently, Castle Biosciences does not sponsor H-1B visas, OPT, or employment-related visas.ABOUT CASTLE BIOSCIENCES INC.At Castle, it all comes down to people. After all, disease doesn't just happen - it happens to people. We believe that disease management and treatment decisions can be better informed through a person's unique biology, which is revealed through the scientific rigor of our innovative, laboratory-developed tests. We are committed to empowering healthcare providers and patients with the goal of improved outcomes. Every employee at Castle has an impact on patient care, and we work to ensure that everyone finds their work to be both challenging and rewarding. We behave with integrity and treat our colleagues with respect and kindness. Our culture fosters an environment of trust, transparency, and collaboration. We prioritize and encourage internal growth and professional development.Castle Biosciences is an equal opportunity employer as to all protected groups, including protected veterans and individuals with disabilities. If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please e-mail <a href="mailto:ReasonableAccommodationsRequest@castlebiosciences.com" target="_blank">ReasonableAccommodationsRequest@castlebiosciences.com</a>.This email was created exclusively to assist disabled job seekers whose disability prevents them from being able to apply online. Only messages left for this purpose will be returned. Messages left for other purposes, such as following up on an application or technical issues not related to a disability, will not receive a response.** No third-party recruiters, please

Castle Biosciences

Lab, Molecular Quality Assurance Technologist (PHX)

At American Express, our culture is built on a 175-year history of innovation, shared values and Leadership Behaviors, and an unwavering commitment to back our customers, communities, and colleagues. As part of Team Amex, you'll experience this powerful backing with comprehensive support for your holistic well-being and many opportunities to learn new skills, develop as a leader, and grow your career.Here, your voice and ideas matter, your work makes an impact, and together, you will help us define the future of American Express.American Express’s Global Financial Crimes Surveillance Unit (GFCSU) is part of the broader Global Risk &amp; Compliance organization, operating within Global Financial Crimes Compliance (GFCC), provides end-to-end oversight and support of global financial crimes investigations. In partnership with broader GFCC teams, GFCSU supports the development, testing, implementation and adjudication of transaction monitoring rules, reports, and other tools to detect potential criminal activity. GFCSU plays a vital role in ensuring compliance with key regulations, including the Bank Secrecy Act (BSA), USA PATRIOT Act, and the Foreign Corrupt Practices Act. They also support law enforcement by providing critical information to combat money laundering, terrorist financing, credit card fraud, identity theft, and other financial crimes.The GFCSU’s Quality Assurance (QA) Team performs regular QA testing of Anti-Money Laundering (AML), Screening, Enhanced Due Diligence (EDD), and Anti-Corruption investigations performed by the Financial Intelligence Unit to ensure adherence to legal and regulatory standards as well as internal procedural requirements.Job Responsibilities:Conduct quality testing of AML, Screening, EDD, and Anti-Corruption processes managed by the GFCSU, which includes evaluating alert investigations against established regulatory and procedural requirements and providing feedback to the relevant team(s)Draft reports to summarize findings and communicate results of quality testing to relevant stakeholders Manage projects to expand and enhance quality review processes and technology Identify trends in investigative quality, potential efficiencies, and procedural enhancements, working closely with GFCC leaders to help improve investigative processes accordinglyMinimum Qualifications:<ul><li>Two+ years of work experience at a financial services institution, retail/commercial bank, or payment processing institution in any of the following areas: AML/BSA, financial crimes compliance, know-your-customer (KYC), enhanced due diligence, screening/sanctions risk management, and/or operational risk</li><li>Proven analytical skills and demonstrated ability to research, assess, interpret, resolve, and remediate issues with regulatory impact</li><li>Excellent time-management skills and demonstrated ability to balance competing priorities in a deadline-driven environment</li><li>Ability to influence, gain support, and resolve conflict</li><li>Detail-oriented with strong verbal and written communication skills</li><li>Proven ability to communicate and collaborate effectively at all levels of the organization</li><li>Self-motivated with an ability to learn quickly and independently</li></ul>Preferred Qualifications:<ul><li>Business Self Testing (BST), Quality Control, or Quality Assurance experience is a plus</li><li>Bachelor’s Degree preferred</li></ul>Salary Range: $55,000.00 to $105,000.00 annually + bonus + benefitsThe above represents the expected salary range for this job requisition. Ultimately, in determining your pay, we’ll consider your location, experience, and other job-related factors.We back you with benefits that support your holistic well-being so you can be and deliver your best. This means caring for you and your loved ones' physical, financial, and mental health, as well as providing the flexibility you need to thrive personally and professionally:<ul><li>Competitive base salaries&nbsp;</li><li>Bonus incentives&nbsp;</li><li>6% Company Match on retirement savings plan&nbsp;</li><li>Free financial coaching and financial well-being support&nbsp;</li><li>Comprehensive medical, dental, vision, life insurance, and disability benefits&nbsp;</li><li>Flexible working model with hybrid, onsite or virtual arrangements depending on role and business need&nbsp;</li><li>20+ weeks paid parental leave for all parents, regardless of gender, offered for pregnancy, adoption or surrogacy&nbsp;</li><li>Free access to global on-site wellness centers staffed with nurses and doctors (depending on location)&nbsp;</li><li>Free and confidential counseling support through our Healthy Minds program&nbsp;</li><li>Career development and training opportunities</li></ul>For a full list of Team Amex benefits, visit our Colleague Benefits Site.American Express is an equal opportunity employer and makes employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability status, age, or any other status protected by law. American Express will consider for employment all qualified applicants, including those with arrest or conviction records, in accordance with the requirements of applicable state and local laws, including, but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance. For positions covered by federal and/or state banking regulations, American Express will comply with such regulations as it relates to the consideration of applicants with criminal convictions.We back our colleagues with the support they need to thrive, professionally and personally. That's why we have Amex Flex, our enterprise working model that provides greater flexibility to colleagues while ensuring we preserve the important aspects of our unique in-person culture. Depending on role and business needs, colleagues will either work onsite, in a hybrid model (combination of in-office and virtual days) or fully virtually.US Job Seekers - Click to view the “Know Your Rights” poster. If the link does not work, you may access the poster by copying and pasting the following URL in a new browser window: <a href="https://www.eeoc.gov/poster" target="_blank">https://www.eeoc.gov/poster</a>Employment eligibility to work with American Express in the U.S. is required as the company will not pursue visa sponsorship for these positions.

American Express

Analyst - Compliance Quality Assurance

Take your career further with McLane! McLane teammates, the driving force behind our success, are diverse professionals who work together seamlessly to keep our operations running smoothly. As a teammate, you will pair your dedication, expertise, and collaborative spirit with your fellow teammates to serve America's most beloved brands. McLane leaders think long-term, act with purpose, and inspire high performance. They lead with accountability, communicate clearly, and drive results through collaboration, innovation, and continuous growth. They empower each teammate to learn from industry leaders, develop their skills, and build lasting connections nationwide. The Safety &amp; QA Special Project Manager uses their knowledge of requirements, regulations, and developments related to quality assurance (QA) and food protection to create and maintain a product protection culture that ensures all operational processes meet QA requirements at all times. They communicate all aspects of safety to the team and ensure that all operational activities are performed in a safe manner. Benefits you can count on: <ul><li>Day 1 Benefits: medical, dental, and vision insurance, FSA/HSA, and company-paid life insurance</li><li>Paid time off begins day one.</li><li>401(k) Profit Sharing Plan after 90 days.</li><li>Additional benefits: pet insurance, maternity/paternity leave, employee assistance programs, discount programs, tuition reimbursement program, and more!</li></ul> What you'll do as a Safety &amp; QA Special Project Manager: <ul><li>Act as a content expert for quality assurance. Must understand all customer QA requirements and relevant government entities. </li><li>Maintain procedures and training manuals required to ensure compliance with QA requirements. </li><li>Perform internal mock audits and serve as primary point of contact for all QA audits.</li><li>Facilitate all federal, state and local inspections of the facility including documentation of the site visit.</li><li>Conduct internal inspections to ensure that all QA records and logs are properly maintained.</li><li>Ensure that all operations are in compliance with government regulations and requirements such as DOT, OSHA, and those of local and state agencies. </li><li>This position has additional duties. Special projects may be assigned at the position supervisor's discretion. </li></ul> Qualifications you'll bring as a Safety &amp; QA Special Project Manager: <ul><li>Have a bachelor's degree in a relevant field.</li><li>Have at least 5 years of warehousing, distribution, QA, and safety experience. </li><li>Have experience managing, training, and directing large work groups.</li><li>Have experience with planning and analytical reporting.</li><li>Be proficient with Microsoft Office programs (Excel, Outlook, Word). </li><li>This position requires the ability to read, write, and understand English at a level sufficient to perform job-related tasks effectively and safely. This includes understanding work instructions, safety protocols, and communications essential to the role. The requirement is directly related to the nature of the job and ensures compliance with workplace safety and operational standards.</li></ul> Fit the following? We want you here! <ul><li>Teamwork oriented</li><li>Organized</li><li>Problem solver</li><li>Detailed </li></ul> Our roadmap. Our story. We've been forging our path as a leader in the distribution industry since 1894. Building an expansive nationwide network of team members for 130+ years has allowed us to stay agile for our clients across the restaurant, retail, and e-commerce industries. We look to the future and are ready to continue making industry-defining moves by embracing the newest technology into our practices, continuing team member training, and emphasizing our people-centered culture. Candidates may be subject to a background check and drug screen, in accordance with applicable laws. All applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. For our complete EEO and Pay Transparency statement, please visit <a href="https://www.mclaneco.com/legal/employment/" target="_blank">https://www.mclaneco.com/legal/employment/</a>

McLane

Safety and QA Special Project Manager

The Office of Technology and Innovation (OTI) leverages technology to drive opportunity, improve public safety, and help government run better across New York City. From delivering affordable broadband to protecting against cybersecurity threats and building digital government services, OTI is at the forefront of how the city delivers for New Yorkers in the 21st century. Watch our welcome video to see our work in action, follow us on social media @NYCOfficeofTech, and visit oti.nyc.gov to learn more. At OTI, we offer great benefits, and the chance to work on projects that have a meaningful impact on millions of people. You'll have the opportunity to work with cutting-edge technology and collaborate with other passionate professionals who share your drive and commitment to making a difference through technology. We are looking for a customer-oriented and collaborative individual to lead the Business Analysis (BA) and Quality Assurance (QA) Unit within the Applications Division. The BA group is charged with eliciting and documenting customer and end user requirements on small to extremely large enterprise technology programs, while QA makes sure the systems work as required by stakeholders. In addition to directing the staff and activities for the unit, the Senior Director will work with other Applications division unit heads to improve quality management within the division. OTI expects to continue to leverage common skills and activities found in the BA and QA roles to cross-train select staff members to work on cross-functional agile teams delivering in a more iterative and continuous manner on projects such as MyCity, NYC 311, Open Data, and NYC.gov. The successful candidate will direct the combined Business Analysis and Quality Assurance groups to develop blended BA and QA roles within an increasingly agile environment using Scaled Agile Framework (SAFe) and Agile Scrum and Kanban methodologies; formulate and guide cross-training plans; promote innovation and user-centric approaches to new solutions; develop new processes that support a fast-paced environment; oversee and possibly create new policies; provide resource management and prioritization oversight; and evaluate possible tools that support the unit. This person will work closely with direct reports to innovate, develop, maintain, and encourage best practices and enforce standards in all areas. Responsibilities will include: -Serve as the Senior Director of the Business Analysis (BA) and Quality Assurance (QA) groups, providing daily direction and mentorship to staff as well as individual consultants, when required. -Manage and coordinate OTI and interagency program, project, and product activities and relationships, as they pertain to the BA and QA functions. -Manage and participate in a professional development program that continuously trains BAs and QA analysts to efficiently deliver quality products. -Manage resource demand, prioritization, and assignments using OTI’s portfolio management tools, in collaboration with other functional managers. -Engage early in the development of a project’s high-level scope, feasibility, and solution design as well as assignment of resources. -Review, evaluate, and provide constructive feedback on BA and QA documentation to ensure the customer receives the highest quality deliverables. -Collaborate with other functional areas in OTI to update, understand, and comply with OTI’s project management, product management, System Development Lifecycle (SDLC), Application Lifecycle Management (ALM), and other methodologies. -Provide direction and leadership concerning tools, processes, and best practices for the Business Analysis function. -Manage oversight of contractor/vendor activities and deliverables for adherence to Applications division standards. -Conduct regular team meetings to instill a culture of openness and bidirectional feedback; and -Collaborate with other functional areas to integrate Human Centered Design practices in analysis and product and project delivery. HOURS/SHIFT Day - Due to the necessary technical management duties of this position in a 24/7 operation, candidate may be on call to work various shifts such as weekends and/or evenings. WORK LOCATION Brooklyn, NY TO APPLY Please go to <a href="http://www.cityjobs.nyc.gov" target="_blank">www.cityjobs.nyc.gov</a> and search for Job ID # 723069 Candidates must be permanent in this title or can be reached on the current civil service list. * Interested applicants with other civil service titles who meet the preferred requirements should also submit a resume for consideration. SUBMISSION OF A RESUME IS NOT A GUARANTEE THAT YOU WILL RECEIVE AN INTERVIEW APPOINTMENTS ARE SUBJECT TO OVERSIGHT APPROVAL NOTE: This position is open to qualified persons with a disability who are eligible for the 55-a Program. Please indicate in your cover letter that you would like to be considered for the position under the 55-a program. OTI participates in E-Verify TELECOMMUNICATION MANAGER - 82984<h4>Minimum Qualifications</h4>1. A baccalaureate degree from an accredited college including or supplemented by 24 credits in the field of voice and/or data telecommunications or in a pertinent scientific, technical, electronic or related area, and four years of satisfactory fulltime experience in the performance of analytical, planning, operational, technical, or administrative duties in a voice and/or data telecommunications or closely related electronics planning, management, and/or service organization, one year of which must have been in a highly specialized capacity and 18 months must have been in an executive, managerial, or administrative capacity or in the supervision of staff performing work in the voice and/or data telecommunications field; or 2. An associate degree from an accredited college including or supplemented by 12 credits in the field of voice and/or data telecommunications or in a pertinent, scientific, technical, electronic or related area and five years of experience as described in "1" above; or 3. Education and/or experience equivalent to "1" above. However, all candidates must have at least a four-year high school diploma or its educational equivalent and one year of the specialized experience as described in "1" above and must possess the 18 months of executive, managerial, administrative or supervisory experience as described in "1" above.<h4>Preferred Skills</h4> The successful candidate should possess the following: -Proven leadership experience managing quality assurance, automation development and business analysis teams. -Strong management experience, either across functional areas or, more specifically, in an IT Business Analysis and/or Quality Assurance group within a technology services delivery environment. -Strong expertise in testing tools and practices, and automation. -Strong expertise in project management methodologies, including Agile, Scrum and Kanban. -Experience developing and employing functional and non-functional requirements documentation artifacts (e.g., Solution Designs, Use Cases, User Stories, Requirements Definitions, Process Definitions, User Interface Designs). -Experience with organizational planning, staff development, team building, and resource allocation/utilization. -Sound judgment in creating and implementing efficient processes, procedures, and continuous improvement strategies that account for organizational culture. -Strong vendor and contract management experience. -Ability to strategically assess a portfolio of initiatives, prioritize needs, allocate resources, and deliver value through partnerships with numerous stakeholders. -Strong written and verbal communication skills, especially honed for executive level and customer communications and presentations. <h4>55a Program</h4> This position is also open to qualified persons with a disability who are eligible for the 55-a Program. Please indicate at the top of your resume and cover letter that you would like to be considered for the position through the 55-a Program. <h4>Public Service Loan Forgiveness</h4> As a prospective employee of the City of New York, you may be eligible for federal loan forgiveness programs and state repayment assistance programs. For more information, please visit the U.S. Department of Education’s website at <a href="https://studentaid.gov/pslf/" target="_blank">https://studentaid.gov/pslf/</a>. <h4>Residency Requirement</h4> New York City residency is generally required within 90 days of appointment. However, City Employees in certain titles who have worked for the City for 2 continuous years may also be eligible to reside in Nassau, Suffolk, Putnam, Westchester, Rockland, or Orange County. To determine if the residency requirement applies to you, please discuss with the agency representative at the time of interview. <h4>Additional Information</h4>The City of New York is an inclusive equal opportunity employer committed to recruiting and retaining a diverse workforce and providing a work environment that is free from discrimination and harassment based upon any legally protected status or protected characteristic, including but not limited to an individual's sex, race, color, ethnicity, national origin, age, religion, disability, sexual orientation, veteran status, gender identity, or pregnancy.

New York City Office of Technology & Innovation (OTI)

Senior Director, Business Analysis and Quality Assurance | City of New York Jobs

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, and Warehouse Operations.The Specialist, QA Shop Floor, Cell Therapy will oversee and partner with operational areas, to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP.Shifts Available:6pm – 6am, rotating scheduling including holidays and weekends, onsiteResponsibilities:<ul><li>Provide routine Quality on-the-floor oversight and triage unexpected events with Manufacturing, Quality Labs, and Supply Chain operations.</li><li>Able to interpret problems and effectively prepare surrounding communication in a productive manner to management and to the group with clarity, brevity, and accuracy.</li><li>Identify departures from approved procedures and respond to issues independently while escalating complex issues to senior members.</li><li>Perform and document operational verification within Manufacturing Execution System (MES) per approved procedures.</li><li>Observe manufacturing operations and identify departures from procedures, cleanroom behaviors and aseptic techniques.</li><li>Provide quality oversight for pre-planned return to service plans.</li><li>Perform area walkthroughs to identify quality issues, propose remediations and support implementation plans with area owners.</li><li>Identify and propose improvements to programs, procedures, and practices.</li><li>Review manufacturing batch records or QC testing records to ensure compliance with approved procedures.</li><li>Review and provide feedback on documents such as forms, logbooks, and procedures.</li><li>Maintain compliance with assigned learning plan. Provide integration support of newer team members.</li><li>Independently approve deviation records within the quality management system consistent with quality risk management principles and in accordance with process knowledge</li><li>Review and interpret the technical conclusions of a record/investigation and provide constructive feedback.</li><li>Participate in quality and shift meetings.</li><li>Build and maintain relationships with core partner functions and seek collaborative solutions.</li><li>Share data/knowledge within team by acting as a champion for quality-culture.</li></ul>Knowledge and Skills:<ul><li>Must be action-oriented and proficient in decision-making, building relationships, problem-solving, and analytical thinking.</li><li>Ability to understand, follow, and apply internal policies, procedures, and quality principles.</li><li>Prior experience with quality processes, including batch record review, material disposition, change control, product complaints, deviations, investigations, and CAPA management.</li><li>Ability to assess an unfolding situation, diagnose the problem, and propose practical solutions.</li><li>Detail-oriented and task-focused with the ability to meet deadlines and prioritize assigned work.</li><li>Ability to work in a fast-paced team environment with changing priorities with limited information and/or time-constraints.</li><li>Effectively communicate with cross-functional peers and various levels of management through technical writing and verbal skills.</li><li>Active listening skills to understand diverse working perspectives.</li><li>Contributes to a positive team environment.</li><li>Able to independently make decisions based on data and facts, and recognizes when to escalate</li><li>Seeks opportunities for improvement to quality and operational problems.</li><li>Ability to work within pharmaceutical cleanroom environments.</li><li>Experience with quality management systems for handling of records such as change control, product complaints, deviations, investigations, and CAPA management.</li><li>Experience with GxP electronic systems such as Manufacturing Execution Systems (MES) for electronic batch records; Enterprise Resource Planning (ERP) such as SAP; laboratory information management systems; or electronic logbooks/forms.</li><li>Proficient with digital tools like Microsoft Power Automate, Smartsheet, Tableau, etc.</li></ul>Basic Requirements:<ul><li>Bachelor's degree in STEM field. High school diploma or associate’s degree with equivalent combination of education and work experience is considered.</li><li>2+ years of relevant cGMP experience with 1+ year of manufacturing site experience.</li><li>Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing.</li></ul>BMSCART#LI-ONSITEGPS_2025If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Compensation Overview:Devens - MA - US: $83,540 - $101,228&amp;#xa;The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.&nbsp; Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit <a href="https://careers.bms.com/life-at-bms/" target="_blank">https://careers.bms.com/life-at-bms/</a>. Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.On-site ProtocolBMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to <a href="mailto:adastaffingsupport@bms.com" target="_blank">adastaffingsupport@bms.com</a>. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:&nbsp;<a href="https://careers.bms.com/california-residents/" target="_blank">https://careers.bms.com/california-residents/</a>Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Specialist, Quality Assurance Shop Floor, Cell Therapy in Devens, MA

Company Profile80 years and countless innovations later, JCB is the world’s largest privately-owned manufacturer of construction and agricultural equipment. At 22 plants spanning four continents—and countries including the United States, the United Kingdom, India and Brazil—JCB manufactures a range of more than 300 products including Loadall telescopic handlers, backhoeloaders, excavators, wheel loaders, compact excavators, skid steer loaders, compact track loaders, Accessaerial work platforms, rough terrain forklifts, and Fastrac tractors.JCB people are at the heart of our business and as a family-owned business we answer to our customers, not a group of shareholders. That freedom allows us to concentrate on developing the latest technologies and incorporating them into our equipment. We focus on what our customer needs on the jobsite – a machine that holds up in the toughest environment and increases their productivity.At JCB, we stand behind our products – and our name.Position PurposeThe Quality Assurance Engineer – Military Programs &amp; ISO 9001:2015 will oversee and manage quality assurance operations for military and defense-related products, ensuring compliance with government regulations, defense standards, and internal quality systems. This role is responsible for two distinct quality programs: one focused on defense and government contract requirements, and the other on the strategic management of the ISO 9001:2015 Quality Management System. The engineer will support audits, maintain certification standards, and drive continuous improvement across all phases of the product lifecycle.Major Tasks, Responsibilities &amp; Key AccountabilitiesDefense Programs:<ul><li>Lead quality assurance activities for military and defense products, ensuring compliance with applicable government and defense standards.</li><li>Serve as the primary quality liaison with agencies such as DCMA, defense contractors, and internal stakeholders.</li><li>Develop, implement, and maintain quality plans, inspection protocols, and control procedures.</li><li>Support and prepare for customer and government audits, ensuring readiness and compliance with contract requirements.</li><li>Maintain documentation and records in accordance with government contract requirements.</li><li>Investigate military product warranty claims, perform root cause analysis, and ensure timely follow-up and closure of corrective actions.</li></ul>ISO 9001:2015 Management:<ul><li>Ensure the Quality Management System (QMS) is implemented, maintained, and continually improved in accordance with ISO 9001:2015 standards.</li><li>Facilitate internal audits, management reviews, and corrective actions to maintain ISO 9001:2015 certification and compliance.</li><li>Monitor and report on quality objectives, performance metrics, and process effectiveness aligned with ISO 9001:2015 requirements.</li><li>Lead risk and opportunity assessments related to quality, supporting strategic planning and operational improvements.</li><li>Train and mentor staff on ISO 9001:2015 principles, promoting a culture of quality and continuous improvement across the organization.</li></ul>Nature &amp; ScopeReports to the Quality Director.Minimum Qualifications<ul><li>Must pass any drug screens, background checks and any pre-employments tests as applicable.</li><li>High school diploma</li><li>Previous manufacturing experience</li><li>Ability to use hand tools</li></ul>Preferred Qualifications<ul><li>Bachelor’s degree in engineering, Quality, or a related technical field.</li><li>5+ years of experience in quality engineering within the defense or military manufacturing sectors.</li><li>Strong knowledge of ISO 9001 requirements.</li><li>Experience with government contracts and working with agencies like DCMA.</li><li>Proficiency in quality tools such as FMEA, SPC, MSA, and root cause analysis.</li></ul>Knowledge, Skills, Abilities &amp; Competencies<ul><li>Expertise in ISO 9001:2015 – Strong understanding of quality management principles, documentation, and audit processes.</li><li>Knowledge of Military &amp; Government Standards – Familiarity with defense regulations, contract requirements, and compliance protocols.</li><li>Root Cause Analysis &amp; Corrective Action – Skilled in structured problem-solving tools like 8D, 5 Whys, and FMEA.</li><li>Audit Management – Ability to lead internal and external audits, including preparation, execution, and follow-up.</li><li>Data-Driven Decision Making – Proficient in analyzing quality metrics to identify trends and drive improvements.</li><li>Clear Communication – Effective in writing reports, presenting findings, and collaborating across departments.</li><li>Project &amp; Program Coordination – Capable of managing both ISO and defense-related quality programs simultaneously.</li><li>Continuous Improvement Mindset – Committed to enhancing processes, systems, and product quality over time.</li></ul>Physical RequirementsThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this job, the employee is regularly required to:<ul><li>Ability to stand or walk for extended periods while performing inspections on the production floor.</li><li>Manual dexterity to handle small parts, tools, and testing equipment.</li><li>Visual acuity to detect defects, read technical drawings, and interpret inspection data.</li><li>Occasional lifting of materials or equipment up to 25–30 pounds.</li><li>Ability to bend, kneel, or reach during inspections or when accessing equipment.</li><li>Comfort working in varied environments, including production areas, warehouses, and outdoor settings.</li><li>Use of personal protective equipment (PPE) such as safety glasses, gloves, and hearing protection as required.</li><li>Ability to travel occasionally, including visits to suppliers, military sites, or audit locations.</li></ul>JCB is an equal employment opportunities (EEO) employer in accordance with applicable federal, state and local laws. JCB complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. EEO EMPLOYER/VET/DISABLED.JCB Inc. is not currently hiring individuals for this position who now or in the future require sponsorship for employment visa status; however, as a global company, JCB offers many job opportunities outside of the U.S. which can be found through our website at <a href="https://www.jcb.com/en-gb/about/careers" target="_blank">https://www.jcb.com/en-gb/about/careers</a>.Disclaimer: This job description is general in nature and is not designed to contain or to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.JobFamilyEngineeringPayTypeSalary

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