Job Summary:
Artiva Biotherapeutics is seeking a skilled and motived Senior Quality Control Associate who will be reporting to the Sr. Manager, Quality Control of Raw Materials. The Senior Associate of Raw Materials will support the qualification and release of raw materials used in GMP manufacturing by coordinating, reviewing, and approving analytical testing performed by contract testing laboratories. This role requires strong technical expertise in wet chemistry, HPLC, and mass spectrometry to critically review external laboratory data, assess suitability for use, and support investigations. The position serves as a key technical interface between internal Quality, Supply Chain, Manufacturing, and external contract laboratories. Experience with ATMPs and biologically derived raw materials is a strong plus.
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
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.
If all this speaks to you, come join us on our journey!
Base Salary: $96,000 - $110,000. Exact compensation may vary based on skills and experience.
