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
Experience writing deviations and investigations.
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
- The Specialist, Continuous Improvement, is responsible for supporting major deviations/investigations and CAPA s in regards to Manufacturing Operations at Cellular Therapeutics. In addition, they will also be responsible for assisting in developing and maintaining various programs and systems to ensure compliance and quality. This may include but not be limited to training, trending and continuous improvement endeavors.