Senior Associate, Quality Control, Raw Materials

Artiva Biotherapeutics•San Diego, CA

7d•$96,000 - $110,000

About The Position

Artiva Biotherapeutics is seeking a skilled and motivated Senior Quality Control Associate who will be reporting to the Sr. Manager, Quality Control of Raw Materials. This individual will support the Raw Materials program with development of new methods or procedures for raw materials testing, coordinating out-sourced testing and working with Sample Management for timely testing turnaround to meet critical material release for manufacturing Artiva’ products.

Requirements

BS or BA or a relevant scientific field, preferably biology or a related field.
At least 4 years of cGMP QC experience in a cell therapy/biotech/pharmaceutical setting is required.
Strong knowledge of raw material testing requirements and regulatory expectations (USP, EP, ICH)
Experience with cell therapy-relevant materials (media, cytokines, sera, reagents, consumables)
Experience with compendial and non-compendial methods
Knowledge and experience in supporting cGMP deviations, OOS, etc.
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

Responsibilities

Perform and verse GMP testing of raw materials, including but not limited to identity, sterility, endotoxin, bioburden, mycoplasma, pH, osmolality, and compendial testing
Execute material qualification activities for new vendors, materials, and alternate suppliers
Review and approve raw material test results and disposition materials in accordance with internal procedures
Ensure timely testing and release to support manufacturing schedules
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
Lead or 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
Coordinate sample shipments for contract testing labs for quality control.
Support or lead QC special projects as needed