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Area: Indiana- Psychiatry &nbsp; Target city for territory is Indianapolis - will consider candidates who live within 100 miles of territory boundaries with access to a major airport. Territory boundaries include: &nbsp;Grand Rapids, MI, Indianapolis, South Bend and Toledo, OH&nbsp; SUMMARY:Are you a results-driven biopharmaceutical sales leader looking to be part of an organization that values being curious, adaptable and accountable? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth!As an Area Sales Manager (ASM) you will be responsible for leading, developing, and managing a diverse, high performing sales team to achieve sales goals for promoted products within our psychiatry portfolio. Set and lead the development of area strategic direction and tactical sales plans using robust analytical skills to identify strengths and opportunities, while minimizing weaknesses and threats to execute those plans and meet or exceed sales goals. &nbsp; ESSENTIAL FUNCTIONS: Leading People • &nbsp; &nbsp;Achieves business objectives and sales results by observing Account Manager interactions with target customers, extended treatment team members, ancillary staff and providing them with individual coaching, feedback and inspiration. Helps Account Manager continue to develop for success in current role and for future growth. • &nbsp; &nbsp;Establishes a result driven highly collaborative team culture by demonstrating personal accountability, teamwork, and collaboration • &nbsp; &nbsp;Leads by example and works collaboratively across functional areas by serving as a resource and by leveraging the expertise of others. • &nbsp; &nbsp;Recruits, develops, and retains diverse, high performing Account Managers to Lundbeck. Knowing the Business • &nbsp; &nbsp;Guides the identification of local market systems of care, patient flow, reimbursement, and provides innovation solutions • &nbsp; &nbsp;Identifies strategic relationships that are valuable to the area’s business (e.g. KOLs, advocacy, P&amp;T committee, etc.) • &nbsp; &nbsp;Actively seeks to discover and meet the needs of internal and external customers by building relationships and delivering innovative solutions. • &nbsp; &nbsp;Ensures that Account Managers can accurately craft Managed Markets selling messages to effectively position Lundbeck’s products within the context of the provider’s setting and payer mix. Managing Execution • &nbsp; &nbsp;Sets and maintains competent product knowledge and selling skills standards within the team. Directs and monitors the execution of approved marketing plans and promotion campaigns. Evaluate and identify improvement and development opportunities of account managers through performance management process to include clear, timely, and actionable feedback on a regular basis. • &nbsp; &nbsp;Facilitates local market execution by aligning the sales force and other cross-functional areas (to include alliance partners), persuading, convincing, or motivating a targeted audience through collaboration and direct or indirect influence. • &nbsp; &nbsp;Analyzes sales reports and develops plan of action. • &nbsp; &nbsp;Maintains timely communication with account managers, management and in-house personnel. Manages multiple priorities and resources related to individual and group efforts. Takes responsibility for redirecting efforts as needed to deliver high productivity and quality of work from self and others. • &nbsp; &nbsp;Assures adherence to all standards, policies, procedures and guidelines as set forth by the organization. &nbsp; REQUIRED EDUCATION, EXPERIENCE and SKILLS: • &nbsp; &nbsp;Bachelor of Arts or Bachelor of Sciences degree from an accredited college or university • &nbsp; &nbsp;External Candidates: &nbsp;Minimum of 3+ years sales management experience in Pharmaceutical, Biopharmaceutical’s, Biologics or related experience. • &nbsp; &nbsp;Internal Candidates must have a minimum of 1 year of Commercial experience in areas such as: Sales Management, Training, Market Access, Sales Operations, or Marketing or a minimum of 2 years consistent sales success within Lundbeck • &nbsp; &nbsp;Documented track record of sales success and financial management. • &nbsp; &nbsp;Demonstrated leadership with the ability to develop, train and provide feedback to a group of account managers. • &nbsp; &nbsp;Must possess superior communication skills, both written and oral. • &nbsp; &nbsp;Driving is an essential duty of this job; must have a valid driver’s license with a safe driving record that meets company requirements • &nbsp; &nbsp;Meeting and complying with reasonable industry-standard credentialing requirements of healthcare providers / customer facilities is required for continued employment with Lundbeck. • &nbsp; &nbsp;Must live within 100 miles of territory boundaries PREFERRED EDUCATION, EXPERIENCE AND SKILLS: • &nbsp; &nbsp;Previous CNS sales management experience&nbsp; • &nbsp; &nbsp;Experience in calling on customers at a variety of call points, including offices, community mental health centers and hospitals • &nbsp; &nbsp;Previous sales management experience and/or experience in other areas of the business; i.e., marketing, sales training, managed care account manager, sales operations, account management is a plus. • &nbsp; &nbsp;Previous experience working with alliance partners (i.e. co-promotions) • &nbsp; &nbsp;Previous experience partnering with Advocacy groups • &nbsp; &nbsp;Previous experience building and developing effective teams • &nbsp; &nbsp;Experience in product launch or expansion within sales &nbsp; TRAVEL: • &nbsp; &nbsp;Willingness/Ability to travel up to 70% domestically to (a) regularly meet/interact with customer base and internal personnel within assigned territory; and (b) attend internal/external conferences and meetings spanning locations within the United States. Travel must be able to be completed in a timely manner. The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate’s geographical location, qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $170,000 - $195,000 and eligibility for a sales incentive target of $51,000, and eligibility to participate in the company’s long-term incentive plan. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, company match 401k and company car. Additional benefits information can be found on our career site. Applications accepted on an ongoing basis.Why LundbeckLundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site.Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.S. career site.Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify.

Lundbeck

Psychiatry Area Sales Manager - Indiana

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.

Bristol Myers Squibb

Sr. Specialist, External Manufacturing Quality 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.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 Document Control Specialist is responsible for the tactical oversight and maintenance of document control system for a new Radiopharmaceutical facility in Indianapolis, IN.&nbsp; The Document Control Specialist will be a primary contact point for document control support.&nbsp; This position will utilize quality assurance knowledge in maintaining the quality program to be ready for clinical development and GMP commercial operations.&nbsp; Additional responsibilities may include providing support for corporate activities.Job ResponsibilitiesEssential duties and responsibilities include the following.&nbsp; Other duties may be assigned.<ul><li>Manage the process for the creation, review, approval, and issuance of GxP controlled site documents and records including batch records, logbooks, forms, procedures, protocols, templates, and reports.</li><li>Manage electronic document management system (EDMS) document lifecycle workflows and assignment of reviewers / approvers and training tasks.</li><li>Review the format and metadata of new documents to ensure compliance with approved templates, procedures and EDMS requirements.</li><li>Provide guidance to document initiators, owners, and users to ensure compliance with all applicable procedures / regulations and assist users with EDMS workflow related issues.</li><li>Manage the periodic review of controlled documents and partner with document owners to ensure periodic reviews are completed within the required timelines.</li><li>Coordinate and liaise with other departments to facilitate uniform quality standards for the site.</li><li>Ensure that compliance to the training program is maintained and updated as needed.</li><li>Process DCR packages and review for correctness and completeness; monitor and update in-process documents.</li><li>Create, assign, and archive QA controlled lab notebooks and logbooks.</li></ul>Education and Experience·BS/MS in a Science related discipline preferred ·3-5 years of quality assurance experience·Pharmaceutical and GMP experience preferred.·Experience working with FDA or other federal and state regulatory bodies.Skills and Qualification·Highly motivated and organized professional with the ability to work independently.·Working knowledge of 21 CFR Parts 11, 210, and 211·Very personable with strong communication skills·Excellent professional ethics, integrity, and ability to maintain confidential information.Physical DemandsWhile performing the duties of this&nbsp;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&nbsp;job&nbsp;include&nbsp;close vision and distance vision.&nbsp;This is a position that requires working in a laboratory environment, protective clothing, gloves, and safety glasses are required while working in a laboratory environment with radioactive materials.Work&nbsp;EnvironmentThe noise level in the&nbsp;work&nbsp;environment is usually moderate.#RayzeBio, #LI-Onsite, GPS_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:Indianapolis - RayzeBio - IN: $34.05 - $41.26per hour&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.

Document Control Specialist

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.The Senior Quality Auditor is responsible for planning, executing, and reporting on internal and external audits to ensure compliance with applicable GxP regulations (GMP, GLP, GCP), internal procedures, and industry standards. This role supports the continuous improvement of RayzeBio’s Quality Management System and ensures readiness for regulatory inspections and commercial operations.&nbsp;Job ResponsibilitiesEssential duties and responsibilities include the following. Other duties may be assigned.<ul><li>Plan, schedule, and conduct audits of internal departments, suppliers, and service providers in accordance with the audit program.</li><li>Evaluate compliance with applicable regulatory requirements (e.g., FDA, EMA, ICH), internal SOPs, and quality agreements.</li><li>Document audit findings and collaborate with stakeholders to develop effective CAPAs.</li><li>Track and verify the implementation and effectiveness of CAPAs.</li><li>Maintain audit records and ensure timely communication of audit outcomes.</li><li>Support regulatory inspections and inspection readiness activities.</li><li>Provide guidance and training on audit processes and GxP compliance expectations.</li><li>Participate in continuous improvement initiatives related to quality systems and audit processes.</li><li>Travel to supplier sites and other company locations may be required.</li></ul>Education and Experience<ul><li>Bachelor’s degree in Life Sciences, Chemistry, or related field is required.</li><li>Minimum of 7-10 years of experience in quality assurance, auditing, or supplier management within the pharmaceutical, biotechnology, or cGMP industry.</li><li>Auditing experience within regulated biotech/pharma industry or equivalent.in a GxP-regulated environment, with at least 3 years in auditing or quality assurance.</li><li>Experience conducting audits across GMP, GLP, and/or GCP domains.</li></ul>Skills and Qualifications<ul><li>Auditor certification (e.g., ASQ CQA, RQAP-GCP) is strongly preferred.</li><li>Familiarity with electronic quality systems and audit management tools is preferred.</li><li>Experience with international audits and regulatory inspections is required.</li><li>Strong knowledge of global GxP regulations and standards (e.g., 21 CFR Parts 11, 210, 211; EudraLex Volume 4; ICH Guidelines) is required.</li><li>Excellent analytical, communication, and report-writing skills are required.</li><li>Must be capable of working independently and handling several tasks simultaneously.</li></ul>Work&nbsp;EnvironmentThe noise level in the&nbsp;work&nbsp;environment is usually moderate.#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: $96,148 - $116,508&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.

Senior Quality Auditor

<h3>Job Description:</h3>To be eligible for consideration of this role, your primary residence must be located within a 90 mile radius at the time of application from the approved branch sites listed below:Indianapolis, CarmelAs a Client Support Specialist, you will be an integral part of a fast-paced, team oriented environment that is focused on enhancing relationships with our high net worth clients who have assets of $250,000 to $1 million and therefore a complex service and investment need. In this role, you will help us to increase customer loyalty and drive business development opportunities.The Team While every Fidelity location has distinctive regional characteristics, each one embodies the core values that have been instrumental in building our proud past. Putting the customer first, respect, integrity, honesty, innovation and improvement as well as competitiveness are values shared across the organization. These simple but powerful values set us apart from our competition.The Expertise You Have<ul><li>Series 7 required</li><li>Series 63 or ability to obtain within 90 days</li><li>2-3 years of previous financial services experience</li></ul>The Skills You Bring<ul><li>Broad based knowledge and understanding of general financial planning concepts</li><li>Proven customer service, client support and problem resolution skills</li><li>Strong verbal and written communication skills</li><li>Ability to effectively influence others</li><li>Robust time management and organizational skills</li></ul>The Value You Deliver<ul><li>Engage with customers, via inbound calls, responding to their inquires which may include providing product and service level guidance, processing transactions to include options, equities, mutual funds and fixed income trades and other specialized monetary requests</li></ul><h3>Certifications:</h3>Series 07 - FINRA, Series 63 - FINRA<h3>Category:</h3>Customer ServiceMost roles at Fidelity are Hybrid, requiring associates to work onsite every other week (all business days, M-F) in a Fidelity office. This does not apply to Remote or fully Onsite roles.Please be advised that Fidelity’s business is governed by the provisions of the Securities Exchange Act of 1934, the Investment Advisers Act of 1940, the Investment Company Act of 1940, ERISA, numerous state laws governing securities, investment and retirement-related financial activities and the rules and regulations of numerous self-regulatory organizations, including FINRA, among others. Those laws and regulations may restrict Fidelity from hiring and/or associating with individuals with certain Criminal Histories.

Fidelity Investments

Client Support Specialist - Greater Indianapolis, IN Area (REMOTE)

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&nbsp;&nbsp; Manager, QA for QC is responsible for quality oversight of the Quality Control (QC) Analytical and Quality Control Microbiology laboratory operations at the RayzeBio facility in Indianapolis in accordance with RayzeBio policies, standards, procedures and global current Good Manufacturing Practice (cGMP). The Senior Manager provides Quality support and oversight for QC laboratory operations such as sample management, testing, and data review, method development, validation, and transfer, equipment validation, and associated projects. The Senior Manager supports thorough review and approval of QC investigations, change control records, Standard Operating Procedures, Method validation and transfer documents, and technical protocols, and assists in preparing for regulatory audits.&nbsp;Job ResponsibilitiesEssential duties and responsibilities include the following. Other duties may be assigned.·Quality Assurance support and oversight of QC (Analytical and Microbiological) laboratory operations including laboratory investigations, deviations, corrective or preventative actions, method development, validation, and transfer activities, equipment validation work and associated projects.&nbsp;·Quality Assurance support of QC associated with the manufacturing process including QC activity related to in process and release product testing, raw material testing, and environmental monitoring activities.&nbsp;·Assesses QC driven change controls and supports completion of any associated change actions.&nbsp;·Participates in ongoing laboratory operations/continuous improvement and risk management projects.&nbsp;·Participates in risk assessments related to QC laboratory operations.&nbsp;·Identifies and reports discrepancies from required work practices or procedures to management.&nbsp;·Makes sound decisions by exercising judgment within generally defined practices and policies and applies appropriate notification to management as appropriate.&nbsp;·Participates as requested in the response team for audits and inspections by health authorities.&nbsp;·Conducts regular walkthroughs of QC laboratories.&nbsp;·Performs review and approval of Quality, Laboratory, and Analytical Standard Operating Procedures (SOPs) and documents.&nbsp;·Provides oversight to identify and implement changes that lead to realization of long-term department and company goals.&nbsp;Education and Experience·Bachelor's degree in engineering or a life or physical science related field (including biology, biochemistry, chemistry) is required.&nbsp; &nbsp;·Minimum 10+ years relevant work experience (analytical development, Quality Control, and/or Quality Assurance), preferably in a regulated environment is required.&nbsp; Quality Assurance experience would be considered beneficial.&nbsp; An equivalent combination of education and experience may substitute.&nbsp;&nbsp;&nbsp;Skills and Qualifications·Knowledge of analytical method lifecycle including development, validation, and transfer&nbsp;·Practical understanding of common QC procedures, techniques, and laboratory equipment/instrumentation and the application and interpretation of most-relevant GMP concepts and compendia requirements (e.g. US FDA, CFR, USP, EP, JP)&nbsp;·Knowledge of Microbiological assay methodologies such as sterility, bioburden, container closure, and endotoxin.&nbsp;·Knowledge of common QC and environmental monitoring procedures and techniques.&nbsp;&nbsp;&nbsp;·Equivalent combination of education and experience acceptable.&nbsp;·Strong background and demonstrated effectiveness in quality assurance operation and compliance of Clinical and commercial Quality laboratory operations.&nbsp;·Strong background and demonstrated effectiveness in quality assurance operation and compliance of clinical/commercial manufacturing is desired.&nbsp;·Knowledge of US, EU and rest-of-world cGMP regulations and guidance.&nbsp;·Knowledge and proven experience in FDA, EMA, or other regulatory authority.&nbsp;·Demonstrated leadership, interpersonal, communication, and motivation skills.&nbsp;·Excellent writing and oral communication skills are required.&nbsp;·Previous work responsibility, which required a high degree of attention to detail.&nbsp;·Well-practiced in exercising sound judgment in decision-making.&nbsp;·Demonstrated prioritization and organization skills.&nbsp;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.  This is a position that requires working in a laboratory environment, protective clothing, gloves, and safety glasses are required while working in a laboratory environment with radioactive materials. The starting compensation for this job&nbsp;is a range from $124,449 - $150,800, plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience. 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&nbsp;offerings&nbsp;are subject to the terms and conditions of the applicable plans then in effect&nbsp;and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support&nbsp;such as&nbsp;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.&nbsp;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.&nbsp;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.#RayzeBio, GPS_2025, #LI-OnsiteWork EnvironmentThe noise level in the work environment is usually moderate.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.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.

Senior Manager - QA for QC

At Texas Roadhouse, we are a people-first company that just happens to serve steaks. Legendary Food and Legendary Service is who we are. We’re about loving what you’re doing today and preparing you for what you’ll be doing tomorrow. Are you ready to be a Roadie?Texas Roadhouse is looking for a Prep Cook who will enjoys preparing made from scratch food that is up to our legendary standards.As a Prep Cook your responsibilities would include:<ul><li>Reading a prep sheet</li><li>Following Texas Roadhouse legendary recipes</li><li>Keeping the walk-in refrigerator clean and organized</li><li>Maintaining and using the equipment properly</li><li>Following storage and rotation procedures</li><li>Maintains proper safety and sanitation practices</li><li>Exhibits teamwork</li></ul>If you think you would be a legendary Prep Cook, apply today!At Texas Roadhouse, our Roadies are the heart and soul of our company. We have a fun culture with flexible work schedules, discounts in our restaurants, friendly competitions, recognition, formal training, and career growth opportunities.Our Roadies are paid weekly. In addition, we offer one of the industry’s most competitive total rewards packages after one year of service to Roadies that meet our benefit eligibility requirements. The total rewards package includes, but is not limited to, the following:<ul><li>A choice of medical plans that are best in class</li><li>Dental and Vision Insurance</li><li>Tuition Reimbursement up to $5,250 annually</li><li>Paid vacation time</li><li>Short-Term Disability</li><li>Life, Accident, and Critical Illness insurance</li><li>Identity Theft Protection</li><li>Employee Assistance Program</li><li>Business Travel Insurance</li><li>Annual holiday bonus</li></ul>We are proud to be an equal opportunity employer. We are committed to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, age, gender, pregnancy, gender identity, disability, veteran status, sexual orientation, citizenship, national origin, or any other legally-protected status. We encourage and welcome all applicants to apply.

Texas Roadhouse

Prep Cook

At Texas Roadhouse, we are a people-first company that just happens to serve steaks. Legendary Food and Legendary Service is who we are. We’re about loving what you’re doing today and preparing you for what you’ll be doing tomorrow. Are you ready to be a Roadie?Texas Roadhouse is looking for a Dishwasher who works well with others while following sanitation guidelines in the kitchen.As a Dishwasher your responsibilities would include:<ul><li>Operating the dish machine</li><li>Supervising proper rinse and wash temperatures</li><li>Changing water, storing, and using dish chemicals properly</li><li>Setting up and organizing the dish racks</li><li>Removing trash</li><li>Maintains proper safety and sanitation practices</li><li>Exhibits teamwork</li></ul>If you think you would be a legendary Dishwasher, apply today!At Texas Roadhouse, our Roadies are the heart and soul of our company. &nbsp;We have a fun culture with flexible work schedules, discounts in our restaurants, friendly competitions, recognition, formal training, and career growth opportunities.Our Roadies are paid weekly. In addition, we offer one of the industry’s most competitive total rewards packages after one year of service to Roadies that meet our benefit eligibility requirements. The total rewards package includes, but is not limited to, the following:<ul><li>A choice of medical plans that are best in class</li><li>Dental and Vision Insurance</li><li>Tuition Reimbursement up to $5,250 annually</li><li>Paid vacation time</li><li>Short-Term Disability</li><li>Life, Accident, and Critical Illness insurance</li><li>Identity Theft Protection</li><li>Employee Assistance Program</li><li>Business Travel Insurance</li><li>Annual holiday bonus</li></ul>We are proud to be an equal opportunity employer. We are committed to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, age, gender, pregnancy, gender identity, disability, veteran status, sexual orientation, citizenship, national origin, or any other legally-protected status. We encourage and welcome all applicants to apply.

Dishwasher

At Texas Roadhouse, we are a people-first company that just happens to serve steaks. Legendary Food and Legendary Service is who we are. We’re about loving what you’re doing today and preparing you for what you’ll be doing tomorrow. Are you ready to be a Roadie?As a Line Cook for Texas Roadhouse, you’ll make made-from-scratch Legendary Food for our guests to enjoy. If you are a team player with a positive attitude and the willingness to learn, apply now, no experience required. We will teach you everything you need to know. Come be a part of something Legendary!What’s in it for you? Glad you asked.<ul><li>Pay – Let’s be honest, we know you’re curious about pay. We offer weekly pay and competitive wages.</li><li>Flexibility – We know you have other commitments outside of work, and we respect that. Our schedules offer hours that work for you.</li><li>People – You’ll be part of a team you can rely on. The folks that work in our kitchens know how to partner up and hustle. Our restaurants are busy, and our hard-working Roadies work together to push out the Legendary Food our guests have come to expect from Texas Roadhouse.</li><li>New Skills – We’ll teach you our recipe for success. You’ll learn our signature, made-from-scratch recipes, plate presentations, how to run a busy station, and our high standards for cleanliness and sanitation.</li><li>Opportunities – We cross-train and often promote from within. Our Legendary training and development programs will give you the opportunity to advance and grow.</li></ul>Wherever you are in life, we have a health and wellness package to meet your needs. Check out our benefits page at careers.becomearoadie.com/us/en for more details.We are proud to be an equal opportunity employer. We are committed to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, age, gender, pregnancy, gender identity, disability, veteran status, sexual orientation, citizenship, national origin, or any other legally protected status. We encourage and welcome all applicants to apply.

Line Cook

At Texas Roadhouse, we are a people-first company that just happens to serve steaks. Legendary Food and Legendary Service is who we are. We’re about loving what you’re doing today and preparing you for what you’ll be doing tomorrow. Are you ready to be a Roadie?Do you feel that you have the potential to be a grill master for Texas Roadhouse? Our legendary steaks are our most popular menu item at Texas Roadhouse, and our Broil Cook position is an important one!As a Broil Cook your responsibilities would include:<ul><li>High volume restaurant experience</li><li>Understand cooking steak temperatures</li><li>Meat seasoning, searing, and cooking</li><li>Meat seasoning, searing, and grilling</li><li>Using proper safety and sanitation guidelines</li><li>Understanding equipment and prep sheets</li><li>Exhibiting teamwork</li></ul>If you think you would be a legendary Broil Cook, apply today!At Texas Roadhouse, our Roadies are the heart and soul of our company. &nbsp;We have a fun culture with flexible work schedules, discounts in our restaurants, friendly competitions, recognition, formal training, and career growth opportunities.Our Roadies are paid weekly. In addition, we offer one of the industry’s most competitive total rewards packages after one year of service to Roadies that meet our benefit eligibility requirements. The total rewards package includes, but is not limited to, the following:<ul><li>A choice of medical plans that are best in class</li><li>Dental and Vision Insurance</li><li>Tuition Reimbursement up to $5,250 annually</li><li>Paid vacation time</li><li>Short-Term Disability</li><li>Life, Accident, and Critical Illness insurance</li><li>Identity Theft Protection</li><li>Employee Assistance Program</li><li>Business Travel Insurance</li><li>Annual holiday bonus</li></ul>We are proud to be an equal opportunity employer. We are committed to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, age, gender, pregnancy, gender identity, disability, veteran status, sexual orientation, citizenship, national origin, or any other legally-protected status. We encourage and welcome all applicants to apply.

81 Jobs in Southport, IN 46227, USA