Quality Assurance Officer Pre-clinical Service & Translational Research
University of Pennsylvania
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Job summary
University of Pennsylvania, located in Kennett Square, PA, seeks a Quality Assurance Officer to manage GLP compliance for PSC-CORL and related facilities. The role ensures audits, SOP reviews, and training while coordinating inspections with FDA, IACUC, and USDA.
The position supports preclinical labs and cross-facility QA activities. The QA Officer will maintain GLP archives, develop SOPs, and guide staff on regulatory compliance, contributing to Penn’s high standards in research integrity and
Qualifications
- Experience working in a GLP environment.
- Strong knowledge of GLPs is required.
- Experience in medical device development and/or gene therapy is preferred.
- Ability to work collaboratively, multi-task, and prioritize in a fast-paced environment.
- Strong analytical skills and attention to detail are required.
- Experience meeting mission-critical deadlines.
- Proficiency with Microsoft Word, Excel, and Access is required.
Responsibilities
- Perform inspections and audits against study protocols and SOPs.
- Review SOPs and training records to ensure standards.
- Review study protocols and final written reports for GLP compliance.
- Conduct facility audits and vendor qualifications.
- Provide corrective actions with input from leadership.
- Train staff on GLP and regulatory compliance.
- Maintain on-site archives of retained study data and coordinate learner onboarding.
Skills
Education
Job description
The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn’s distinctive interdisciplinary approach to scholarship and learning. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America’s Best Large Employers in 2023. Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play. The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.
Quality Assurance Officer Pre-clinical Service & Translational Research
Research Specialist C
The Quality Assurance Officer’s activities are critical to ensuring compliance with Good Laboratory Practices (GLP) at the New Bolton Center’s preclinical research labs. The Quality Assurance Officer is responsible for maintaining GLP compliance at the Preclinical Service & Translational Research Core and for continuing GLP compliance development on a contracted basis at the Retinal Disease Studies Facility (RDSF). He/she will be performing audits of the Preclinical Service Core against written study protocols and Standard Operating Procedures (SOP); reviewing SOPs and updating formatting to comply with GLP standards; perform study protocol and final written report reviews; perform facility audits as well as pre-audit inspections; and with input from the laboratory’s Director, use their discretion and independent judgment in providing recommended corrective actions to management and the study directors. He/she coordinates onboarding of pre-vet students entering the program. He/she is responsible for facilitating any on-site inspections (both FDA, sponsor QA, IACUC and USDA.), as well as performing routine vendor qualification inspections or re-qualifications. The QA-officer is also responsible for maintaining the GLP archive of retained study data on-site and must provide guidance and regular training to staff as it relates to GLP and compliance. Position located in Kennett Sq., No public transport available.
As the Quality Assurance Officer, you will function as the manager of PSC-CORL’s FDA Good Laboratory Practices (GLP) compliance program. Your role is to provide ongoing support and improvement of PSC-CORL’s quality system by:
- performing inspections and audits against written study protocols and Standard Operating Procedures (SOP);
- reviewing SOPs and training records to comply with our standards;
- performing study protocol and final written report reviews;
- performing facility audits and vendor qualifications;
- with input from the PSC-CORL Director, use your discretion and independent judgment in providing recommended corrective actions to management and the study directors;
- providing guidance and training to internal and external department staff on GLP and regulatory compliance;
- and maintaining the on-site archives of retained study data.
- coordinates onboarding of pre-vet students entering the program.
In this role, you will also provide support to the research efforts of another preclinical research facility on New Bolton Center’s campus, the Retinal Disease Studies Facility (RDSF). On a contracted basis, you will be responsible for providing ongoing QA support and guidance for the implementation of a GLP compliance program at their facility.
Provide monthly and annual GLP training to staff and study directors; maintain GLP training documentation; maintain the GLP archives’ organizational system and process archive submissions as needed; facilitate on-site inspections; maintain corrective action logs; report periodically to management regarding overall facility compliance status; educate supporting New Bolton Center departments on GLP and maintain inter-departmental relationships.
Periodic study inspections and audits of raw study data; review draft study protocols and amendments for GLP compliance; perform full final study report audits; perform annual facility audits of PSC-CORL and supporting New Bolton departments; perform vendor audits and two-year requalifications on-site and off-site as needed.
Maintain logs of inspection and QA records; manage SOP development and approval; maintain master study schedule records; verify training records.
Support and guide the process of developing a GLP compliance program at RDSF; coordinate with senior staff to develop SOPs, provide staff training, review protocol templates, and perform facility inspections.
Coordinate learner training at all levels (PreVet Res Assistants, Techs, Fellows and graduate students) concerning overall program compliance with emphasis on GLP, IACUC and USDA regulations.
- Experience working in a GLP environment and strong knowledge of GLPs required
- Experience in medical device development and/or gene therapy is preferred.
- Demonstrated ability to work collaboratively, multi-task, and prioritize in a fast-paced environment is a must.
- Strong analytical skills and attention to detail are required.
- Must have demonstrated experience meeting mission-critical deadlines.
- Experience with Microsoft Word, excel, and access is required.
Research Specialist C: Bachelor's degree in life sciences and 3-5 years of experience in a quality assurance role or an equivalent combination of education and experience required.
Research Specialist D: Master of Science or higher degree and a minimum of 3-5 years of experience in a quality assurance role or an equivalent combination of education and experience required. A master’s degree in Regulatory Affairs or a Registered QA Professional certification is preferred.
Office, Library, Computer Room; Laboratory requires extensive safety
Typically sitting at a desk or table; Occasional lifting 25 lb. or less
Kennett Square, Pennsylvania
School of Veterinary Medicine
$58,506.00 - $90,000.00 Annual Rate
Salary offers are made based on the candidate’s qualifications, experience, skills, and education as they directly relate to the requirements of the position, and in alignment with salary ranges based on external market data for the job’s level. Internal organization and peer data at Penn are also considered.
The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law.
Background checks may be required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
- Health, Life, and Flexible Spending Accounts: Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family’s health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.
- Tuition: Take advantage of Penn's exceptional tuition benefits. You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions.
- Retirement: Penn offers generous retirement plans to help you save for your future. Penn’s Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard.
- Time Away from Work: Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family—whatever your personal needs may be.
- Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility. If you apply when you’re newly hired, you won’t have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always provide proof of good health and are subject to underwriting.
- Wellness and Work-life Resources: Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life. That’s why we offer a wide variety of programs and resources to help you care for your health, your family, and your work-life balance.
- Professional and Personal Development: Penn provides an array of resources to help you advance yourself personally and professionally.
- University Resources: As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities. Take advantage of the University’s libraries and athletic facilities, or visit our arboretum and art galleries. There’s always something going on at Penn, whether it’s a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to name just a few examples. As a member of the Penn community, you’re right in the middle of the excitement—and you and your family can enjoy many of these activities for free.
- Discounts and Special Services: From arts and entertainment to transportation and mortgages, you'll find great deals for University faculty and staff. Not only do Penn arts and cultural centers and museums offer free and discounted admission and memberships to faculty and staff. You can also enjoy substantial savings on other goods and services such as new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks.
- Flexible Work Hours: Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments. These approaches involve use of non-traditional work hours, locations, and/or job structures.
- Penn Home Ownership Services: Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, which can be used for closing costs or home improvements.
- Adoption Assistance: Penn will reimburse eligible employees on qualified expenses in connection with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household.
To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay
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