Specialist I, Quality Assurance

Role: Quality Assurance Specialist I supporting manufacturing operations in a biopharma setting, primarily focusing on batch record review, product and raw material disposition, and quality documentation management. Objectives include ensuring compliance with cGMP standards, streamlining quality processes, and supporting continuous improvement initiatives. Responsibilities encompass reviewing and approving batch records, managing deviations, CAPAs, change controls, and supporting complaint and APR programs. Requires on-the-floor manufacturing support and SAP master data SME functions. Qualifications: Bachelor's in scientific field, minimum 5 years of cGMP quality experience, expertise in batch review, product/raw material disposition, and validated SAP systems. Experience with large molecule (biologics) manufacturing, US/EU pharma regulations, and GMP principles is essential. High-value specifics include supporting GMP manufacturing for biologics, managing Deviations, CAPAs, and APR/PQR, and working in a senior technician role within a regulated environment. Collaboration: cross-functional with QC, Manufacturing, Supply Chain, and Quality teams. Work setup: unspecified, but involves on-site support at Canton, MA; no travel specified.