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.
The QA Technical Specialist will meet quality and compliance expectations for assigned areas on time, right-first-time and implement assigned compliance improvements.
MAJOR ACTIVITIES AND RESPONSIBILITIES:
- To provide compliance assessment and support to the customers for deviations, laboratory OOS investigations and change controls related to QC laboratory testing, test method and analytical instrumentation
- Participates on project teams and collaborates with owners throughout the project lifecycle ensuring analytical compliance.
- Works with internal departments to drive continuous improvement in the Laboratory state of compliance under limited supervision.
- Reviews laboratory data, ensuring compliance to specifications.
- Reviews Raw Material and Stability COAs and Reports.
- Reviews method validation/stability protocols and reports, instrument qualification documents, ensuring that protocol and testing requirements align with established industry standard and internal documentation.
- Serves as QA contact for QC, Analytical PD and the Clients for analytical issues.
- Revises and reviews master plans, SOPs, work instructions and training course plans for analytical instrument operation, stability and analytical test methods, ensuring alignment with qualification documentation.
- Serves as SME during audits for analytical issues, as needed.
- Help oversee the development, implementation and maintenance of, and compliance to, department procedures and policies
Education + Years of Experience
- BS/BA +6 years of experience or;
- MS/PhD +0 years of experience
- LIMS experience preferred
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.