Principal Associate II, Quality Assurance Operations

Role: Quality Assurance Specialist overseeing GMP batch release, product compliance, and inspection readiness in a biopharma manufacturing setting. Responsibilities: manage batch disposition, review testing records, oversee product complaints, ensure GMP conformity, and lead investigations into deviations and out-of-specifications; support regulatory audits and drive continuous quality improvements. Requirements: Bachelor's in science (chemistry, biology, biochemistry, microbiology); 6+ years in GMP/QA within biopharma or biologics industries; strong knowledge of GxP, FDA, EU GMP, and ICH guidelines; experience with quality systems like Master Control or Veeva; proficiency in MS Office and document revision. Preferred: Master’s or PhD, experience managing product complaints, handling quality events, and familiarity with clinical and commercial supply processes. High-Value: Focus on biologics manufacturing, GMP compliance, batch release, and quality systems in a regulated environment. Work setup: based in Framingham, MA, with a 5-day on-site requirement.