QA Technical Specialist (Software Validation)

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 site located in Research Triangle Park, NC.

Primary responsibilities will be to function as a Quality Assurance SME, with limited supervision, to review and approve software/automation related GMP documents.  Hands on experience with one or more of the following types of systems/applications is required:  EDMS, Track Wise, LIMS, Delta V, SAP. Working knowledge of GAMP and Part 11 is required.

Essential Functions and Duties:

  • With limited supervision, function as the QA SME for software/applications
  • QA approve software/automation GMP documents in accordance with FDB requirements
  • Communicate cross functionally with peers and QA management
  • Lead small QA groups to investigate, recommend improvements, and monitor effectiveness
  • Provide highly collaborative, cross-functional support within the QA Organization

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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