Duties/Responsibilities: Coordinate submission of raw material samples to qualified contract testing laboratories, including preparation of testing requests, timelines, and documentation Serve as the primary QC point of contact for external laboratories performing raw material testing Ensure testing is performed per approved specifications, compendial methods, and quality agreements Perform technical review and approval of raw material test results generated by contract laboratories, with emphasis on: Wet chemistry data, HPLC chromatographic data and trends, Mass spectrometry-based identity and impurity assessments Evaluate data for compliance with specifications, GMP requirements, and data integrity expectations Identify atypical results, trends, or discrepancies and initiate follow up with vendors as needed Support qualification and oversight of biologically derived raw materials commonly used in ATMP and cell therapy manufacturing (e.g., media components, cytokines, growth factors, enzymes) Collaborate with QC Biology and Manufacturing teams to ensure raw material controls are appropriate for ATMP applications Author, review, and approve GMP documentation including SOPs, test methods, protocols, reports, deviations, CAPAs and change controls Maintainer accurate and compliant laboratory records in LIMS, ELN, and paper-based systems Support internal, external, and regulatory audits (FDA, EMA, etc.) Act as a subject matter expert (SME) for raw material testing methods and regulatory expectations Troubleshoot assay failures, out-of-specification (OOS, and out-of-trend (OOT) results Support method transfers, verifications, and validations for raw material assays Evaluate supplier documentation including BSE/TSE, CoAs, COC, COI, technical packages, SDS and quality agreements Identify opportunities to improve testing efficiency, data integrity, and compliance Support implementation of new technologies, methods, and systems Participate in cross-functional teams with QA, Manufacturing, Materials Management and Product Development Support or lead QC special projects as needed. Experience of raw material testing requirements and regulatory expectations (USP, EP, ICH) Experience with cell therapy-relevant materials (media, cytokines, sera, reagents, consumables) Experience supporting material qualification and release through contract testing laboratories.