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<h4>Overview</h4>LMI is seeking an experienced Regulatory Affairs Manager to support the Office of Human and Animal Research Oversight (OHARO), Office of Human Research Oversight (OHRO) at Ft.&nbsp;Detrick in Frederick, MD location. Will serve as lead auditor for quality audits (GMP &amp; GLP) of developing and manufacturing investigational countermeasures for MCS. This position can be performed hybrid/remotely with onsite requirements 1 day per week. This position requires the ability to pass a T1/ NACI security investigation. You must be a U.S. citizen.LMI is a consultancy dedicated to powering a future-ready, high-performing government, drawing from expertise in digital and analytic solutions, logistics, and management advisory services. We deliver integrated capabilities that incorporate emerging technologies and are tailored to customers’ unique mission needs, backed by objective research and data analysis. Founded in 1961 to help the Department of Defense resolve complex logistics management challenges, LMI continues to enable growth and transformation, enhance operational readiness and resiliency, and ensure mission success for federal civilian and defense agencies.LMI has been named a 2024 #BestPlacestoWork in the United States by Built In! We are honored to be recognized as a company that values a people-centered culture, and we are grateful to our employees for making this possible!<h4>Responsibilities</h4><ul><li>Provide expert analysis and advice on the development, management and improvement of quality systems and procedures to ensure compliance with all applicable laws, regulations and organizational quality standards in support of GXP activities.</li><li>Build and maintenance of Quality KPIs/Metrics, and Documentation and Data Controls Programs for maintaining compliance to the QMS regulations, guidelines and the QM/RA organization directives, and that QMS documentation is effectively implemented, controlled, maintained, stored, archived, protected and retrievable.</li><li>Provide advice and aid in the implementation of quality systems and procedures to ensure compliance with all applicable laws, regulations, and organizational quality standards in support of advanced development activities.</li><li>Assess results and progress relative to objectives across projects and communicate periodically/as needed to relevant leadership and stakeholders through the conduct of supplier evaluation visits (e.g., due diligence, audits, vendor qualifications, etc.). This will include the following:<ul><li>Inspection of contract laboratories or other facilities, providing data in support of GLP studies to assure compliance with GLP guidelines, applicable protocols, and SOPs</li><li>Periodic facility audits of facilities, equipment, and records required by GLPs</li><li>QMS audits of ISO/FDA elements related to the control of documents and data</li><li>Regulatory agency inspections, including sponsor/monitor inspections and clinical investigator site inspections</li><li>GCP training and the development and maintenance of GCP-related quality systems</li><li>GCP compliance audits of investigator sites, CRO facilities, and vendors, including clinical sample labs in accordance with audit plans</li><li>Internal and external current GMP audits in support of the supplier evaluation program to identify and evaluate all risks </li></ul></li><li>Remain flexible to changing priorities and ideas while keeping project milestones on track.</li><li>Propose and implement solutions to critical problems by creating actionable strategies and implementation plans to reallocate resources or efforts as required, as well as oversight plans that use metrics for monitoring progress.</li></ul><h4>Qualifications</h4><ul><li>Required: Master's degree in Life Sciences, Public Health, Medical, Nursing, Pharmacy, Veterinary, Business, Technical or Medical Writing, or a related discipline, as well as eight (8) years of relevant experience; or PhD in Life Sciences, Public Health, Medical, Nursing, Pharmacy, Veterinary, Business, Technical or Medical Writing, or a related discipline, as well as six (6) years of relevant experience serving as a Regulatory Affairs Manager performing:<ul><li>Laboratory and facility inspections in support of GLP studies &nbsp;</li><li>Facility audits as required by GLPs &nbsp;</li><li>QMS audits of ISO/FDA elements &nbsp;</li><li>Regulatory agency inspections </li><li>GCP training &nbsp;</li><li>GCP compliance audits &nbsp;</li><li>Internal and external current GMP audits &nbsp;</li></ul></li><li>Be capable of maintaining interpersonal contacts to increase effective team dynamics; effectively communicating ideas, requirements, and scientific knowledge; and self-starting.</li><li>Preferred: Certification in Regulatory Affairs or other certification relevant to medical product development and/or audit, is desired and will be at no cost to the Government.</li><li>Possess and maintain a mastery of FDA regulations, inferences, and regulatory requirements, and have the capability to interpret and apply them to COVID-19 Product Development and Fielding efforts.</li><li>Possess expert knowledge in regulatory affairs and quality assurance as it relates to pharmaceutical development, as well as previous experience applying this knowledge in a regulatory/quality organization providing support throughout the product development lifecycle including pre-clinical, non-clinical and clinical study development and implementation, and medical product manufacturing development efforts. In addition, candidate shall be capable of applying this expert knowledge to complex technical problems with minimal supervision.&nbsp; </li><li>Ability to pass a T1/ NACI security investigation. You must be a U.S. citizen.</li></ul>Target salary range: $114,444 - $180,000Disclaimer:&nbsp;The salary range displayed represents the typical salary range for this position and is not a guarantee of compensation. Individual salaries are determined by various factors including, but not limited to location, internal equity, business considerations, client contract requirements, and candidate qualifications, such as education, experience, skills, and security clearances.<h4> LMI is an Equal Opportunity Employer. LMI is committed to the fair treatment of all and to our policy of providing applicants and employees with equal employment opportunities. LMI recruits, hires, trains, and promotes people without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, pregnancy, disability, age, protected veteran status, citizenship status, genetic information, or any other characteristic protected by applicable federal, state, or local law. If you are a person with a disability needing assistance with the application process, please contact <a href="mailto:accommodations@lmi.org" target="_blank">accommodations@lmi.org</a> Colorado Residents: In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Need help finding the right job? </h4>We can recommend jobs specifically for you!Click here to get started.

LMI Consulting, LLC

Regulatory Affairs Manager

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.

Texas Roadhouse

Dishwasher

ABOUT GREYSTARGreystar is a leading, fully integrated global real estate company offering expertise in property management, investment management, development, and construction services in institutional-quality rental housing, logistics, and life sciences sectors. Headquartered in Charleston, South Carolina, Greystar manages and operates more than $320 billion of real estate in 250 markets globally with offices throughout North America, Europe, South America, and the Asia-Pacific region. Greystar is the largest operator of apartments in the United States, manages more than 977,000 units/beds globally, and has a robust institutional investment management platform comprised of more than $78 billion of assets under management, including over $36 billion of development assets. Greystar was founded by Bob Faith in 1993 to become a provider of world-class service in the rental residential real estate business. To learn more, visit <a href="http://www.greystar.com" target="_blank">www.greystar.com</a>. JOB DESCRIPTION SUMMARYThis position is responsible for coordinating the community’s marketing, leasing, and renewal strategies to achieve occupancy, revenue, and resident retention goals by performing all activities related to leasing to new residents, providing resident satisfaction throughout the term of the lease, and securing resident lease renewals.JOB DESCRIPTIONEssential Responsibilities: •&nbsp;&nbsp; &nbsp;Performs all sales and leasing activities to achieve the community’s revenue and occupancy goals by greeting and qualifying prospects, conducting community tours and showing apartments, processing applications, credit screening, and criminal background checks, preparing the lease and move-in package, and ensuring a smooth resident move-in and lease signing. &nbsp;&nbsp; •&nbsp;&nbsp; &nbsp;Inspects apartments prior to resident move-in and ensures apartments are in move-in ready condition and schedules any outstanding item to be addressed with the maintenance team.&nbsp; •&nbsp;&nbsp; &nbsp;Stays informed about current market and competitor conditions that may impact the community’s occupancy and sales results, develops and implements short- and long-term marketing plans and goals to sustain occupancy, and follows the community’s established policies related to concessions, specials, and other programs to boost occupancy.&nbsp; •&nbsp;&nbsp; &nbsp;Designs and executes marketing activities to create and drive traffic to the community, including implementing resident referral and employer outreach programs, using internet marketing tools (Craigslist, Facebook, e-mail, and other websites), and following other community-specific marketing plans, drives, and special programs.&nbsp; •&nbsp;&nbsp; &nbsp;Uses the on-site property management software (OneSite, Yardi, etc.) to track apartment availability, record traffic and leasing activities, manage resident and prospect data, and capture critical demographic and other information about existing and future residents.&nbsp; •&nbsp;&nbsp; &nbsp;Ensures that the community and show units meet the Company’s standards for show quality by daily inspecting the marketing corridor and leasing tour, communicating maintenance and upkeep needs to the community’s maintenance team members, merchandising and ensuring a physically appealing show unit and/or model and amenities, and preparing the leasing office for daily leasing activities.&nbsp; •&nbsp;&nbsp; &nbsp;Follows-up with prospects and new residents to ensure satisfaction by sending e-mail, thank-you notes, and cards or making telephone calls or other contacts to finalize decisions to lease and/or renew.&nbsp; •&nbsp;&nbsp; &nbsp;Executes and performs activities in support of the community’s lease renewal program by preparing lease renewal letters and packages for residents, meeting with and contacting renewing residents in advance of move-out dates, and ensuring that lease renewal documents are signed and implemented on time. &nbsp; &nbsp; &nbsp; &nbsp; •&nbsp;&nbsp; &nbsp;Responds quickly and courteously to resident and client/owner concerns and questions, and takes prompt action to solve problems and/or document and convey resident or other requests to the appropriate individual(s). &nbsp;Required Licenses or Certifications: •&nbsp;&nbsp; &nbsp;Incumbents must have all licenses and/or certifications as required by State and Local jurisdictions•&nbsp;&nbsp; &nbsp;Incumbents must have valid driver’s license to operate a golf cart on property.The hourly range for this position is $20 - $21.Additional Compensation:<ul><li>Corporate Positions:&nbsp;In&nbsp;addition to the base salary, this role may be eligible to participate&nbsp;in&nbsp;an annual bonus program based on&nbsp;individual and company performance.</li><li>Onsite Property Positions:&nbsp;In&nbsp;addition to the base salary, this role may be eligible to participate&nbsp;in weekly, monthly, and/or quarterly bonus programs.</li></ul>Robust Benefits Offered*:<ul><li>Competitive Medical, Dental, Vision, and Disability &amp; Life&nbsp;insurance benefits. Low (free basic) employee Medical costs for employee-only coverage; costs discounted after 3 and 5 years of service.</li><li>Generous Paid Time off. All new hires start with 15 days of vacation, 4 personal days, 10 sick days, and 10 paid holidays. Plus your birthday off after 1 year of service! Additional vacation accrued with tenure.</li><li>For onsite team members, onsite housing discount at Greystar-managed communities are available subject to discount and unit availability.</li><li>6-Week Paid Sabbatical after 10 years of service (and every 5 years thereafter).</li><li>401(k) with Company Match up to 6% of pay after 6 months of service.</li><li>Paid Parental Leave and lifetime Fertility Benefit reimbursement up to $10,000 (includes adoption or surrogacy).</li><li>Employee Assistance Program.</li><li>Critical Illness, Accident, Hospital&nbsp;Indemnity, Pet&nbsp;Insurance and Legal Plans.</li><li>Charitable giving program and benefits.</li></ul>*Benefits offered for full-time employees. For Union and Prevailing Wage roles, compensation and benefits may vary from the listed&nbsp;information above due to Collective Bargaining Agreements and/or local governing authority.Greystar will consider for employment qualified applicants with arrest and conviction records.

Greystar

Leasing Professional - The Park at Walnut Ridge

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 Server at Texas Roadhouse, get ready to smile, serve up some fresh-baked bread, and create a legendary dining experience our guests will never forget. Bring your friendly energy, enthusiasm, and willingness to learn.Apply now, no experience required. We will teach you everything you need to know!What’s in it for you? We’re glad you asked.<ul><li>Pay – Our restaurants are busy. You can make great money and have fun. Plus, we pay weekly.</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 that is full of hard-working folks you’ll enjoy working with. Together, we will wow our guests with the Legendary Service they’ve come to expect from Texas Roadhouse. You’re never on your own when you’re working with us.</li><li>Opportunity – Learning now can pay off later in promotions and growth for your career. We often promote from within, and our legendary training and development programs can help you grow with us.</li></ul>Wherever you are in life, we have a health and wellness package to meet your needs. Check out our benefits page at <a href="https://careers.becomearoadie.com/us/en" target="_blank">https://careers.becomearoadie.com/us/en</a> 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.

Server

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?Are you interested in working with people in a fun and fast-paced environment? If so, we have the job for you! Texas Roadhouse is looking for Server Assistants-Bussers to join our team.As a Server Assistant-Busser your responsibilities would include:<ul><li>Assisting guests with their needs</li><li>Helping servers attend to their tables</li><li>Clearing and cleaning tables quickly</li><li>Practices proper safety and sanitation procedures</li><li>Exhibiting teamwork</li></ul>If you think you would be a legendary Server Assistant-Busser, 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.

Server Assistant - Busser

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.

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?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 <a href="https://careers.becomearoadie.com/us/en" target="_blank">https://careers.becomearoadie.com/us/en</a> 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?Texas Roadhouse is looking for a To-Go Roadie to support our carry out operations, execute high standards of food quality and service, and ensure our To-Go guests experience the same Legendary Food and Legendary Service as our dine-in guests.As a To-Go Roadie your responsibilities would include:<ul><li>Ensuring each guest receives a legendary welcome and goodbye when placing and/or picking up their order</li><li>Uses proper phone etiquette when answering calls and taking orders</li><li>Knowledgeable of menu to accurately take and place orders</li><li>Demonstrates strong organization and accuracy when packaging orders</li><li>Works collaboratively with Back of House staff to complete orders</li><li>Partners with Restaurant Managers on quote times; accurately provides quotes to guests on the length of time to complete their order</li><li>Understands our online and mobile app ordering systems</li><li>Accurately uses point of sale (POS) system to place orders, process To-Go sales, gift card sales, and cash/credit card transactions</li><li>Practices proper safety and sanitation procedures</li><li>Exhibits teamwork at all times</li></ul>If you think you would be a legendary To-Go Roadie, 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.For more information about this position, please contact the restaurant and ask for a manager.

21 Full Time Jobs in Hagerstown, MD, USA