Cambridge Metro Area, MA
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.