Edison-New Brunswick Metro Area, NJ
- Author investigations and support resolution of product complaints, Out Of Expectation, Out Of Specification, Out of Tolerance results
- Use process knowledge and root cause investigation tools to identify root causes of product and process deviations.
- Supports documentation of experimental plan, execution, and results to support investigations
- Ensures robustness (complete, accurate and defendable) of all critical and major investigations
- Work cross-functionally to assess and analyze deviations and investigations to determine impact
- Proven process understanding (Pharma, GMP, Regulatory aspects). Desirable MSc. or equivalent experience.
- Minimum 3 years experience in GMP manufacturing role on the shop floor and/or QA/QC.
- BSc. in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree.