Fujifilm Manufacturing USA, Inc

Sr. QC Associate

Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Life Sciences or related field, or equivalent experience
  • 5+ years of experience in quality control or related area
  • Proficient in cell-based analytical methods
  • In-depth knowledge of regulatory compliance and Good Documentation Practices
  • Experience participating in method validation and transfer processes
  • Strong communication skills for training and collaboration
  • Ability to lead projects and manage timelines effectively

Responsibilities

  • Perform routine testing for in-process and final product quality
  • Serve as a subject matter expert for analytical methods
  • Participate in analytical method transfer and validation
  • Draft and review laboratory SOPs and technical documents
  • Train and mentor QC Associates for knowledge transfer
  • Model compliance and quality culture in documentation practices
  • Support inspections, audits, and lead preparation projects
  • Conduct investigations and implement solutions for nonconformance
  • Assist in laboratory equipment validation processes
  • Lead or participate in projects to ensure timely completion

Benefits

  • Working with a leading company in cell therapy
  • Opportunity for professional growth and career advancement
  • Access to state-of-the-art laboratory facilities
  • Collaborative and supportive team environment
  • Engagement in continuous learning and development programs
  • Participation in compliance-focused projects and initiatives
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
NASDAQ

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