"Quality Assurance Analyst (Regulatory) CVPF (Center for Cellular Immunotherapy)"

Quality Assurance Analyst (Regulatory) CVPF (Center for Cellular Immunotherapy)

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.

Posted Job Title
Quality Assurance Analyst (Regulatory) CVPF (Center for Cellular Immunotherapy)

Job Profile Title
Research Coordinator

Job Description Summary
The Quality Assurance Analyst will work within the Clinical Cell and Vaccine Production Facility (CVPF) for the review and release of investigational cell and gene therapy products for human administration manufactured at our facility.

This position is contingent upon funding.

Job Description

Job Responsibilities

• Review of manufacturing batch records and product release documentation under tight deadlines with impact on patients and clinical teams for early phase I/II first-in-human clinical development. Verify calculations, chain of custody, and all applicable records adhere to GDP, cGMP and applicable internal SOPs.
• Communicate errors and deviations identified during batch record review. Communicate effectively with cross functional teams to ensure on time delivery of QA review, errors are resolved and investigations are initiated and progressing in a timely manner.
• Issue verified chain of custody labels and prepare the release paperwork including Certificate of Analysis, shipping records for final infusible products.
• Conduct apheresis product receipt of fresh and frozen apheresis product collected and cryopreserved by CCI internal and external multi-center sites. Coordinate and follow-up with apheresis collection and cryopreservation site for addressing all observations during the receipt.
• Conduct verification of packaging, and releasing of final infusible product to administration sites.
• Anticipate potential roadblocks that may affect product release and alert management and cross functional teams within and outside of the Center for Cellular Immunotherapies, as applicable. Other Duties as assigned by management.
• Assign, and maintain the Eternal Report, and CVPF Correspondences.
• Review other control quality documents such as SOPs, WIs, and guidance as needed.

Qualifications

• Bachelor of Science and 1 to 2 years of experience or equivalent combination of education and experience is required.
• Bachelor's degree in Biology or related science preferred.
• 1-3 years of experience in a GLP/GCP/GMP setting, or equivalent, with >1 year of direct experience in Quality role preferred.
• Excellent verbal and written communication skills and interpersonal skills.
• Detail oriented, and Excellent organizational record keeping.
• Flexibility to work with schedule changes.
• Knowledge of manufacturing biologics product and cell and gene therapy principles and technologies preferred.
• Working knowledge of FACT Common Standards for Cellular Therapy preferred.