QA Manufacturing Specialist
Edison-New Brunswick Metro Area, NJ
- B.S. in a scientific or engineering discipline
2 or more years relevant experience, preferably in a GMP or regulated environment
- Must have Cellular or Gene Therapy biopharmaceutical product experience
- Must have strong background in CAPA and Quality in support of manufacturing processes
- Knowledge of manufacturing investigations, cell culture process
- Responsibilities Include
Initiate deviations and perform routine investigations.
Participate in cross functional investigative teams deploying specific investigative principals
as necessary to ensure root cause analysis and corrective action(s).
Ensures corrective actions and improvements are shared and incorporated into the
Generate and execute CAPA documents to support response to deviations, audit findings and
independent corrective actions.
Collaborate with QC team to prioritize and lead Continuous Improvement initiatives
Train team for CAPA related findings.