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 Specialist in our Contract Manufacturing site located in Research Triangle Park, NC. Primary responsibilities will be to support the review of QC generated batch data, stability data, PRs, deviations and help in LIMS COA issuance.
Major Activities and Responsibilities:
- Complete assigned quality and compliance duties on time, right-first-time, in compliance with SOPs – 80-95%
- Contributes from assigned functions as team member – 0-10%
- Keep current with required site training. Set, monitor, and report progress on goals and development activities – 5-10%
Essential Functions and Duties
- Review laboratory data, ensuring compliance to specifications
- Review raw material and stability COAs and Reports
- Review deviations, laboratory OOS investigations related to QC laboratory testing
- Support Activities associated with analytical data review
- Monitor Trackwise system for Invalids, Laboratory OOS investigations and deviation PRs related to assigned projects
- Review executed QC Laboratory and manufacturing documentation for completeness and accuracy
- Participate in Quality “on the floor” initiatives and “real-time” record review
- Maintain designated trackers and metrics as required
- Provide cross-functional support within the QA Organization
Minimum Education Requirements
- 2+ 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.