QA Technical Specialist (Vendor Auditing/Quality)

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.

We are seeking a highly motivated individual to join us as a QA Technical Specialist in our Contract Manufacturing site located in Research Triangle Park, NC.

Primary responsibilities will be to support QA Supplier Management and Material Disposition for the facility. CQA is preferred. Approximately 25% travel required.

Essential Functions and Duties:

  • Conduct, coordinate and facilitate external audits and follow-up activities for various types of suppliers including, but not limited to: materials, contract laboratories, service providers.
  • Develop audit reports, follow-up letters and other communications to suppliers. Provide on time follow-up to QA management regarding audit findings. Ensure suppliers have appropriate CAPAs in place for any GMP deviations found.
  • Prepare Supplier packages for QA management approval
  • Manage Supplier Change Notifications
  • Perform review and QA disposition of materials

 

Minimum Education Requirements

  • BS/BA

Desired Experience

  • 6+ years of applicable experience

 

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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