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 for multiple or complex Quality Assurance systems and compliance activities. Under limited supervision, the Senior QA Technical Specialist assists to establish and meet quality and compliance requirements in Multiple Compliance Areas.
MAJOR ACTIVITIES AND RESPONSIBILITIES:
- Meet quality and compliance expectations for assigned areas on time, right-first-time, and implement approved compliance improvements
- Compliance 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
- Risk management of materials to phase appropriate standards to include clinical and commercial programs.
Education + Years’ Experience
- BS/BA +8 or MS/PhD+2
- Experience with Trackwise and SAP preferred
- Excellent oral and written skills
- Sitting 50- 90%; Standing and walking; 10- 50%; Lifting up to 25 lbs. (Document Boxes) or 50 lbs. (QA Materials group); Ability to use PPE for Manufacturing, warehouse, and Lab Areas
- Experience working in a GMP facility
- Follow SOPs, understands and applies principles behind Std Practices and regulations behind the SOPs
- SME for internal and external Compliance functions with limited supervision
- Well-developed problem solving skills to identify and solve problems within the SOP, Std Practice, and regulatory framework. Can lead small cross-functional groups to investigate, recommend improvements to management, and monitor effectiveness of improvements for unique issues
Decision Making/Conflict Resolution
- Can make decisions within the SOP, std practice, and regulatory framework for compliance areas in which they are an SME and can assist others in cross functional peer conflict resolution
- Communicate cross functionally with peers, management, and external customers in oral, presentation, and written forms
- Employee consistently demonstrates positive inclusive behaviors, consistently promotes positive team attitude, and supports business objectives
- 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.