Quality Control Analyst III

Role: The QC Technical Operations Analyst III supports quality and compliance from development through commercialization by executing routine and non-routine analytical testing, participating in data trending, investigations, and laboratory operations. Responsibilities include performing assays for raw materials, in-process samples, and product release, maintaining training and documentation, qualifying methods, and supporting laboratory maintenance and audits. The role emphasizes continuous improvement, regulatory compliance (GMP, GLP, ICH), and collaboration across departments such as CMC, manufacturing, and QA. Qualifications: B.S. in chemistry, biology, or biochemistry, with 6-10 years’ GMP QC experience; expertise in method transfer and validation; strong data analysis, technical writing, and problem-solving skills; proficiency in LIMS and MS Office preferred. High-value: biopharma manufacturing support, analytical method lifecycle management, GMP compliance, and cross-functional team collaboration. Work setup: onsite in Norton, MA, with occasional responsibilities in Cambridge, MA.