Quality Operations Specialist II

Location: Remote
Compensation: Salary
Staff Reviewed: Wed, Mar 27, 2024
This job expires in: 13 days

Job Summary

A company is looking for a Senior Specialist II, Quality Operations.

Key Responsibilities:
  • Provide QA expertise in support of commercial manufacturing and batch disposition activities
  • Provide QA approval of deviations and investigations related to batch manufacturing (and testing)
  • Capture and provide key performance indicator data for progress and risk visibility to leadership
Required Qualifications:
  • Bachelor's degree in Scientific field required
  • Minimum of five (5) years of industry experience, ideally with commercial drug product experience
  • Knowledge of GxP requirements, basic quality system tools, and aseptic processing
  • Experience managing disposition activities
  • Technical understanding of biopharmaceutical production, with cell and gene therapy experience a plus

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