Senior Analyst, Quality Control (Raw Materials)

Role: Senior QC Analyst specializing in raw materials testing for biopharmaceutical manufacturing, ensuring cGMP compliance and quality standards. Responsibilities: perform complex analytical assays (HPLC, GC, XRPD, Karl Fischer), review/test data, lead investigations on deviations, author SOPs/methods, support method validation/transfer, collaborate across QA, manufacturing, supply chain, coordinate external testing, mentor junior staff, participate in audits. Requirements: Bachelor's in Chemistry, Biochemistry, or related field; 5+ years GMP QC laboratory experience focused on raw materials; proficiency with analytical instrumentation and pharmacopeial standards (USP, EP, JP); familiarity with LIMS, Empower. Preferred: experience with regulatory submissions, ICH/FDA/EMA guidelines, and continuous improvement initiatives. High-Value: experience with excipients, active ingredients, solvents; expertise in analytical techniques and regulatory compliance in pharmaceutical QC setting. WorkSetup: laboratory environment, on-site in Bedford, MA; safety protocols in place.