cGMP Quality Control Associate

The University of Southern California (USC) is seeking a cGMP Quality Control Associate to join the USC/CHLA cGMP facility. The successful candidate will conduct analytical testing, support product testing and documentation, and maintain operations to ensure the quality and regulatory compliance of cell and gene therapy products.

Requirements

• Performs cell culture, media preparation, cryopreservation, cell expansion, and viral vector production under strict cGMP guidelines.
• Executes aseptic processing, (e.g., cell seeding, passaging, harvesting, and transduction using viral vectors).
• Works closely with manufacturing, PD, QA, and QC teams to align processes, troubleshoot issues, and enhance efficiency.
• Conducts routine cleaning, calibration, troubleshooting, and maintenance of equipment and analytical instruments to ensure compliance with cGMP standards.
• Performs analytical testing for product release, stability, and in-process monitoring and support in assay qualification.
• Supports GMP documentation control, Corrective and Preventive Actions (CAPA) and change control processes to maintain quality standards.
• Assists in internal and external audits, batch record review, and deviation investigations to uphold regulatory and quality standards.
• Assists in training operators and new team members on manufacturing procedures, QC testing, and process development protocols.
• Maintains compliance with all safety protocols, regulatory requirements, and workplace standards.