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 Specialist – Compliance in our Contract Manufacturing site located in Research Triangle Park, NC. Primary responsibilities will be to support the GMP compliance systems oversight for the facility.
Major Areas of Responsibility
- Strong individual contributor with an outstanding ability to collaborate with technical teams responsible for analytical test method development, transfer, qualification and validation.
- Reviews and approves analytical documents such as test method qualification, validation, transfer documents with set standards of efficiency.
- Reviews and approves TOC test method qualification studies
- Reviews and update existing Procedures to bring them into compliance with Company standards and objectives
- Monitor Trackwise system for deviation PRs related to assigned projects
- Maintain spreadsheets that track monthly performance and other key metrics
- Has understanding of ICH guidelines and evaluative process to ensure achievement of quality goals
- Partner with subject matter experts to conduct investigations
- Ensure proper root cause analysis using various investigative techniques.
- Works cross-functionally in identifying appropriate corrective/preventative actions designed to increase method robustness
Qualification and Requirements:
- Bachelor’s Degree is required. A focus degree in Science is preferred. 4+ years of pharmaceutical/FDA regulated facility or other GMP regulated environment.
- Individual must demonstrate the following:
- Ability to read, analyze and interpret common scientific and technical documents.
- Strong written and verbal communication skills. A technical writing background is preferred.
- Proven investigational skills including prior experience using root cause analysis tools.
- Strong decision-making/analysis skills, problem-solving and Lean mindset.
- Thorough understanding of compliance requirements and ability to follow detailed written procedures.
- Ability to handle multiple, at times complex tasks and prioritize and adapt to business needs.
- Proficient in Microsoft Office Suite of programs (Word and Excel is required, Visio, Project, PowerPoint, and Access skills are 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.