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

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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

This position is a crucial component of the success of on-going human clinical trials in immunotherapies. Main duties include:

• 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