Quality Operations Specialist II

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