Fujifilm Manufacturing USA, Inc

Sr. QC Associate

Fujifilm Manufacturing USA, Inc • $75K — $95K *
Thousand Oaks, CA 91360In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in a scientific discipline or equivalent experience.
  • 5+ years of experience in a quality control or laboratory setting in the biotechnology field.
  • Familiarity with cell-based assays and compendial testing methodologies.
  • Strong understanding of Good Documentation Practices (GDP) and compliance regulations.
  • Experience in troubleshooting analytical methods and conducting investigations.

Responsibilities

  • Perform routine testing for in-process, intermediates, and final products.
  • Act as a subject matter expert for analytical methods and troubleshooting.
  • Participate in analytical method transfers and validation processes.
  • Draft and review laboratory SOPs and technical documents.
  • Train and support QC Associates in best practices and knowledge sharing.
  • Ensure a culture of quality through compliance with ALCOA++ standards.
  • Support management during internal and external inspections and audits.

Benefits

  • Collaborative work environment fostering professional growth.
  • Opportunities for involvement in diverse projects and method validations.
  • Commitment to a culture of quality and compliance.
  • Access to advanced laboratory technologies and methodologies.
Full Job Description
Position Overview

Fujifilm Biotechnologies California is hiring a Sr. Associate Quality Control to support our One Cell Therapy Business located in Thousand Oaks, California.

Job Description

Primary 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 6370;70% of the time with the remainder of the time dedicated to assigned projects.


About Fujifilm Manufacturing USA, Inc

Fujifilm Manufacturing USA, Inc is a subsidiary of Fujifilm Holdings Corporation, a Japanese multinational conglomerate that specializes in imaging and photography. Fujifilm Manufacturing USA, Inc is responsible for the manufacturing of photographic paper, film, and other imaging products in the United States. The company was established in 1988 and has its headquarters in Valhalla, New York. Fujifilm Manufacturing USA, Inc operates as a subsidiary of Fujifilm North America Corporation.
Learn more about Fujifilm Manufacturing USA, Inc
Size
72,332 employees
Industry
Manufacturing & Automotive
NASDAQ
FUJIF
* Ladders Estimates

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