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Scientific. Clinical. Software Engineering

Manufacturing Investigator

Edison-New Brunswick Metro Area, NJ

Job Type: Scientific Job Number: JN -042019-24729 Region: Edison-New Brunswick Metro Area

Job Description

  • 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.
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