What are the responsibilities and job description for the Cell & Gene Therapy QC Associate position at RevereIT LLC?
Job Title: Cell & Gene Therapy QC Associate
Location: Research Triangular Park, NC
Responsibilities:
- Perform aseptic cell therapy operations including cell expansion, harvesting, and cryopreservation in a GMP cleanroom environment.
- Support gene therapy production processes including viral vector preparation, transduction, and purification steps under sterile conditions.
- Conduct microbiological testing such as environmental monitoring, bioburden, and endotoxin testing to ensure aseptic integrity.
- Execute Quality Control assays related to cell viability, identity, sterility, and gene expression analysis.
- Maintain and review detailed batch records, SOPs, and QC documentation in compliance with pharmaceutical quality standards.
- Collaborate with cross-functional teams including Manufacturing, QC, QA, and Microbiology to troubleshoot and maintain compliance throughout the process lifecycle.
