Sr. QC Associate

Fujifilm•Thousand Oaks, CA

3d•Onsite

About The Position

At FUJIFILM Biotechnologies California, we’re driving the future of medicine with the expertise to produce life-changing cell therapies like T-cell and CAR T immunotherapies. Working with pioneering biotech partners, our teams manufacture innovative treatments that improve lives. Join us at our advanced Thousand Oaks facility, where you’ll make a tangible impact on groundbreaking therapies. We offer a collaborative, flexible workplace and a vibrant culture driven by passion and energy—what we call Genki. If you’re ready to reimagine the future of healthcare, let’s create something extraordinary together. Our campus is in Thousand Oaks, California, an exceptional place to live with great schools, natural beauty, outdoor activities, and proximity to Los Angeles and Santa Barbara. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers Overview Fujifilm Biotechnologies California is hiring a Sr. Associate Quality Control to support our One Cell Therapy Business located in Thousand Oaks, California. External US

Requirements

Sr. Associate Quality Control

Responsibilities

Performs routine testing for in-process, intermediates, final product, and stability of clinical and/or commercial lots including cell-based methods (e.g., viable cell count, Immunophenotyping, cytotoxicity, proliferation) as well as compendial testing (pH, Osmolality, Endotoxin, appearance, on the floor visual inspection).
May act as subject matter expert for analytical methods, troubleshooting, investigations and/or technical reports as assigned by management.
May participate in the analytical method transfer and/or validation, as well as critical reagents qualifications.
Draft, revise and review laboratory SOPs, test methods and technical documents under guidance of management.
Train/support and work closely with QC Associates to ensure transfer of knowledge, collaborative role modeling of professional constructive problem solving.
Role models compliance and Good Documentation Practices (ALCOA++) ensuring a culture of quality and procedural adherence.
Supports management during internal and external inspections and audits.
May lead projects aiding in preparation for inspection.
Support nonconformance investigations, root cause analysis and implement solutions as assigned by management.
Support laboratory equipment validations, as needed and assigned by management.
Participate and or lead projects under management leadership and ensure timely completion.
Ensure laboratory and documentation compliance with applicable company requirements and global regulations.
Expected to participate in testing and lab upkeep tasks ≥70% of the time with the remainder of the time dedicated to assigned projects.