Quality Assurance Specialist

Kindeva Drug Delivery
Any Location, MO
Category Healthcare
Job Description
Quality Assurance Specialist II provides advanced quality oversight and exercises judgment in product disposition, investigations, and change control. Applies specialized knowledge to resolve quality issues, lead investigations, and ensure timely product release. Partners with cross-functional teams to implement improvements and maintain compliance with regulatory standards.

Requirements

  • Bachelor's degree in Chemistry, Biology, Microbiology, Pharmacy, Engineering, or other science-related discipline or a minimum of 3 years experience in the Pharmaceutical or related industry
  • Experience in Batch Record Review/Audit/Disposition
  • Knowledge of cGMPs (USFDA, Health Canada, PIC/S and/or Eudralex)
  • Certified Quality Auditor (CQA) Certification preferred
  • Ability to complete aseptic gowning qualification and work in a Grade A/B classified area
  • Ability to sit, stand and occasionally lift items (up to ~25 pounds)
  • Ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements

Benefits

  • Generous Paid Time Off
  • 401k Matching
  • Retirement Plan
  • Health Insurance
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