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 Senior QA Technical Specialist in our Contract Manufacturing site located in Research Triangle Park, NC. The position acts as the subject matter expert (SME) for multiple or complex Quality Assurance supplier management and material release activities under limited supervision. Successful candidate will have a proven track record of managing projects and cross-functional collaboration.
Essential Functions and Duties:
- Meet quality and compliance expectations for assigned areas on time, right-first-time, and implement approved compliance improvements
- Act as area SME and may lead compliance projects
- Keep current with required site training and external compliance requirements for assigned compliance areas. Set, monitor, and report progress on goals and development activities
- Management of suppliers including supplier auditing, report writing, and response resolution.
- Supplier monitoring activities including complaint management and scorecard activities
- Quality Agreement negotiations with new and existing suppliers
- Engage in regulatory and client audits in regards to Supplier Quality and Material Management
- Evaluation and approval of material item specifications, indicating approval for use.
- Risk management of materials to phase appropriate standards to include clinical and commercial programs.
- Represent QA Supplier Management and Materials Release for internal/external audits and regulatory inspections.
Minimum Education Requirements
- 8+ years of applicable experience
- This position may require up to 20% travel
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.