Snr QA Specialist
Wayne Metro Area, NJ
Snr QA Specialist -
- Seeking QA Professionals experienced in Quality supporting CAPAs, SOPs, Manufacturing investigation and related for biopharmaceutical processes.
- Knowledge of FDA, GMP, qualification and validation practices.
- Ability to assist with QA Audits
- Oversees QA compliance for manufacturing, conducts investigations and ensures CAPAs are resolved in timely fashion.
B.S Biology, Engineering or related life science degree
5 years experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics preferred.
Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (Investigation report, CAPA report, SOPs etc.) required.
Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc.
Familiar with FDA, ISO, and other regulatory agency guidelines.
Understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) required.
Working knowledge and technical understanding of aseptic manufacture of biologics preferred.
Experience in both clinical and commercial manufacturing is preferred.