Quality Assurance Specialist II

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