Quality Assurance Specialist II

Job Summary

A company is looking for a Senior Specialist, Quality Assurance (Level II & III).

Key Responsibilities

• Review and approve batch records, technical protocols, deviations, and equipment qualification protocols
• Execute shop floor quality audits in sterile pharmaceutical manufacturing environments
• Provide QA oversight for sterile process validation and/or technology transfer

Required Qualifications

• Level II (Associate): 2+ years in the Pharmaceutical Industry, Associate's degree with strong relevant experience considered
• Level III (Senior): 5+ years in the Pharmaceutical Industry
• Bachelor's degree in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, or related field
• Working knowledge of regulatory expectations for sterile pharmaceutical manufacturing and testing
• Experience with SAP and/or Manufacturing Execution Systems (e.g., PAS-X) preferred