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MFG Specialist II - Compliance

Genezen

📍 Lexington, MA

Posted 5 months ago

Quick Info

Experience Level

Mid Level

Minimum Degree

Master

Department

Quality Assurance Control
0

Job Type

Full Time

Specialty Skills

cGMPDeviation InvestigationsCAPAChange ControlProcess Improvement

About the Role

The MFG Specialist in this role will be part of a cohesive team responsible for Deviation investigations, CAPAs, and Change Controls for all phases of manufacturing. The Manufacturing Specialist uses expert knowledge of cGMP regulations and project management to ensure manufacturing readiness and compliance. The incumbent will also support equipment, documentation and process operations improvement initiatives within Manufacturing. The MFG Specialist works independently with minimal supervision and direction. Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion.

About Genezen

Therapies for autoimmune and inflammatory diseases

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