Job Description

Job Title: Cell & Gene Therapy QC Associate

Location: Research Triangular Park, NC

Responsibilities:

1. Perform aseptic cell therapy operations including cell expansion, harvesting, and cryopreservation in a GMP cleanroom environment.
2. Support gene therapy production processes including viral vector preparation, transduction, and purification steps under sterile conditions.
3. Conduct microbiological testing such as environmental monitoring, bioburden, and endotoxin testing to ensure aseptic integrity.
4. Execute Quality Control assays related to cell viability, identity, sterility, and gene expression analysis.
5. Maintain and review detailed batch records, SOPs, and QC documentation in compliance with pharmaceutical quality standards.
6. Collaborate with cross-functional teams including Manufacturing, QC, QA, and Microbiology to troubleshoot and maintain compliance throughout the process lifecycle.

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