QA Technical Specialist, CSV
Research Triangle Park, North Carolina
The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We’re 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 FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. Here, you’ll work alongside and learn from some of the most dedicated scientists, engineers, and manufacturers in the industry. We’re proud to cultivate a culture that will fuel your passion, energy, and drive—what FDB calls Genki. Join us and discover a community that thrives on diversity and never scares away from a complex challenge. At FDB, you determine what’s possible.
As we grow our community, our capacity, and capabilities significantly in the next year, we’re looking for passionate people to join our global team.
We are seeking a highly motivated individual to join us as a QA Technical Specialist at our 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, TrackWise, LIMS, DeltaV, ABB, UNICORN, SAP. Working knowledge of GAMP, validation, data integrity principles and 21 CFR Part 11 is required. QA Technical Specialist will attend project meetings, provide compliance/GMP input when needed and escalate any issues pertaining to compliance accordingly.
Essential Functions and Duties:
- With limited supervision, function as the QA SME for software/applications and data integrity
- QA approval of 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
- Support data integrity initiatives
Minimum Education Requirements
- BS/BA in scientific/engineering discipline
- Prior experience (6+ years) in a quality assurance, engineering, or scientific position in the biotechnology/pharmaceutical industry
- Knowledge of validation principles and GAMP 5
- Solid understanding and application of GMP regulations, including 21 CFR 210, 211 as they pertain to computer system validation
- Solid understanding of data integrity guidance from FDA and MHRA as well as knowledge and application of 21 CFR Part 11 and EU Annex 11
- Decision-making and problem solving skills
- Good interpersonal skills; team player; ability to collaborate with cross-functional teams
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.