QA Specialist (Sample & Stability Logistics)

We are ‘Advancing tomorrow’s medicines’ and making a real difference to the world in which we live. At Fujifilm Diosynth Biotechnologies, we partner with our clients to deliver recombinant proteins, viral vaccines and gene therapies to patients. As a Contract Development & Manufacturing Organization (CDMO), our focus is to combine technical leadership in cell culture, microbial fermentation and viral vectors with world class GMP manufacturing facilities to advance tomorrow’s medicines. We seek candidates with proven ability to work independently and collaboratively to achieve optimized strategies, and execution programs with the ultimate goal of delivering products that transform the lives of patients.

Position Summary:

The QA Specialist position assists laboratory management with the coordination of sample and stability logistics. The position may also support other laboratory activities as required.

Main responsibilities include:

  • Performs stability study sample set up and removal from chambers, including sample time point pulls and sample submission
  • Responds to chamber alarms and moves materials within retain and stability chambers as required
  • Performs sample set up and documentation for QA retain program functions, ensuring annual inventory is completed on time
  • Performs sample receipt and tracking, including but nt limited to TempTale reports and shipment preparations
  • Serves as Logistics contact for Manufacturing, warehouse, Planning and QD for sample, stability and material issues
  • Provides off-hour coverage for the Logistics group as needed
  • Revises and reviews SOPS and work instructions for material control
  • Serves as back-up SME during audits for Logistics issues, as needed
  • Other duties as assigned

Minimum Education Requirements

  • BS/MS in relevant Science or Engineering discipline

Desired Experience

  • 2+ years of experience in a laboratory cGMP pharmaceutical environment, including 2 years scheduling laboratory activities.

FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company’s ability to secure an export authorization. FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.

FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.

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