Quality Assurance Specialist

Job Summary

A company is looking for a Quality Assurance Specialist responsible for reviewing and approving GMP investigations in a biopharma manufacturing facility.

Key Responsibilities

• Independently review and approve GMP investigations, ensuring compliance with cGMP regulations
• Investigate non-conformances, deviations, OOS/OOTs, and other quality events
• Collaborate with cross-functional teams to support product quality and patient safety

Required Qualifications

• Associate or Bachelor's degree preferred
• 5+ years of hands-on experience in quality assurance roles
• Experience in QA investigation review within a GMP regulated manufacturing setting
• Familiarity with Vault QMS is a plus