A cutting-edge cell therapy company is looking for a QC Associate to join their team! With plenty of growth potential, this role will support technical operations and manufacturing.
- Supports QC-Analytical management during internal and external inspections and audits.
- Supports nonconformance investigations, and root cause analysis.
- Performs routine testing on in-process and final product clinical and commercial lots.
- Supports the qualification of a GMP compliant QC bioanalytical laboratory.
- Helps to draft SOPs and test methods. May also help with technical reports, and qualification or verification protocols.
- Supports troubleshooting, investigations, technical reports, and protocol writing/revision.
- Quality Control experience in the pharmaceutical industry supporting cGMP areas, including assay validation preferred.
- Bachelor's Degree in Biochemistry, Molecular and Cellular Biology, Immunology, or Biology.
- 1+ years of experience or an equivalent combination of education and experience.
- Experience in cGMP cell therapy manufacturing and/or testing facility is a plus.
- Knowledge of relevant regulations and FDA guidance is desired.