Senior Associate, Quality Control, Raw Materials

Duties/Responsibilities

• Cook up 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
• Maintain 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, COCs, COIs, technical packages, SDS, and quality agreements
• Identify opportunities to improve testing efficiency, data integrity, and compliance
• Support implementation of new technologies, methods, and systems
• Support or lead QC special projects as needed

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Analytical Chemistry, or related scientific discipline
• 4+ years of experience in GMP QC or analytical roles, with demonstrated experience reviewing and approving external laboratory data
• Strong technical knowledge of wet chemistry testing principles, HPLC data interpretation and troubleshooting, Mass spectrometry (LC‑MS or similar) concepts
• 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
• Solid understanding of GMPs, data integrity, and QC documentation practices
• Basic knowledge of method transfers, qualifications, and validations; current industry practices; and strong experience with guidance interpretation and application
• Excellent critical thinking and technical writing skills
• Computer skills required to operate Microsoft Word, Project, Visio, and Excel programs