Quality Assurance Officer Pre-clinical Service & Translational Research at The University of Pennsylvania in New Bolton Center

Job description

University Overview 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. Posted Job Title Quality Assurance Officer Pre-clinical Service & Translational Research Job Profile Title Research Specialist C Job Description Summary 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. Job Description 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 1) performing inspections and audits against written study protocols and Standard Operating Procedures (SOP); 2) reviewing SOPs and training records to comply with our standards; 3) performing study protocol and final written report reviews; 4) performing facility audits and vendor qualifications; 5) with input from the PSC-CORL Director, use your discretion and independent judgment in providing recommended corrective actions to management and the study directors; 5) providing guidance and training to internal and external department staff on GLP and regulatory compliance; 6) and maintaining the on-site archives of retained study data. 7) coordinates onboarding of pre-vet students entering the program In this role, you will also provide support to the research effort