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

The University of Pennsylvania is a world-renowned leader in education, research, and innovation. This position involves working within the Clinical Cell and Vaccine Production Facility (CVPF) for the review and release of investigational cell and gene therapy products for human administration.

Job Responsibilities

• Review of manufacturing batch records and product release documentation under tight deadlines to ensure adherence to GDP, cGMP, and internal SOPs.
• Communicate errors and deviations, and coordinate with cross-functional teams for timely resolution and investigations.
• Issue verified chain of custody labels and prepare release paperwork, including Certificate of Analysis and shipping records.
• Conduct apheresis product receipt, verification, packaging, and release of final infusible products.
• Anticipate potential roadblocks affecting product release and alert management and teams as needed.
• Assign and maintain the Eternal Report and CVPF Correspondences.
• Review other quality control documents such as SOPs, WIs, and guidance.

Qualifications

• Bachelor of Science and 1 to 2 years of experience, or equivalent combination; degree in Biology or related science preferred.
• 1-3 years of experience in a GLP/GCP/GMP setting, with at least 1 year in a Quality role preferred.
• Excellent verbal and written communication, interpersonal skills, detail-oriented, and organizational skills.
• Flexibility with schedule changes; knowledge of biologics manufacturing and cell and gene therapy principles preferred.
• Working knowledge of FACT Common Standards for Cellular Therapy preferred.

This position is contingent upon funding and is a crucial component of ongoing human clinical trials in immunotherapies.

Pay Range

$44,500.00 - $65,000.00 Annual Rate