Quality Control Associate, Analytical at FUJIFILM Holdings America Corporation

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join our new FDB facility in Thousand Oaks, CA and help manufacture the next cell therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.  We are searching for a Quality Control Analytical Associate to support and perform routine testing of final product and stability testing using basic analytical techniques including pH, Osmolality, Endotoxin, Appearance as well as cell counting utilizing cell counters.

External US

Quality Control Associate

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join our new FDB facility in Thousand Oaks, CA and help manufacture the next cell therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

Reports to: Supervisor, Quality Control

Location: Thousand Oaks, CA

Primary Responsibilities:

• Supports and performs routine testing of final product and stability testing using basic analytical techniques including pH, Osmolality, Endotoxin, Appearance as well as cell counting utilizing cell counters.
• Performs cell culture thaw and maintenance activities in support of more advanced assays. Weekend work occasionally required.
• Participate in and perform final product visual assessment on the MFG floor.
• Participates in laboratory upkeep activities (instrument maintenance, cleaning, organization, re-stocking) as needed.
• Participate in basic document revision of laboratory SOPs, test methods and technical documents.
• Support internal and external inspections and audits by completing assigned prep activities in a timely manner.
• Participate and support nonconformance investigations, root cause analysis and implement solutions as assigned.
• Ensure the laboratory and documentation is in compliance with applicable company requirements and global regulations.

Qualifications:

• Basic laboratory skills (e.g. Pipetting, aseptic technique).
• Knowledge of basic compendial testing and cell based analytical methods and respective instrumentation a plus.
• Strong detail-oriented mindset.
• Experience working with radioactive isotopes a plus.
• Basic knowledge of document management lifecycle.
• Basic understanding of quality systems and their interconnections (e.g., LIMS, document revisions, change control, deviations, CAPA).
• Basic knowledge of computer systems (e.g. Word, Excel, LIMS)
• Basic knowledge of inspection/audit readiness.
• Bachelor’s Degree in Biochemistry, Molecular and Cellular Biology, Immunology, or Biology.
• High School diploma with 6+ years of experience; or Associates degree with 4+ years of direct laboratory experience; or Bachelors of Science (B.Sc.) with 0-3 years of experience.
• Role model for company core values of trust, delighting our customers, Gemba, and Genki.

Salary and Benefits:

• $30.50 to $36.50 per hour, depending on experience
• Medical, Dental and Vision
• Life Insurance
• 401k
• Paid Time Off

Join us! FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community and the world at large.

FDBC is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, religious creed, sex (includes pregnancy, childbirth, breastfeeding, and related medical conditions), and sexual orientation and any other status protected by state or federal law.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.