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QA Technical Specialist, Methods

Research Triangle Park, North Carolina

The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We’re growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. Here, you’ll work alongside and learn from some of the most dedicated scientists, engineers, and manufacturers in the industry. We’re proud to cultivate a culture that will fuel your passion, energy, and drive—what FDB calls Genki. Join us and discover a community that thrives on diversity and never scares away from a complex challenge. At FDB, you determine what’s possible.

As we grow our community, our capacity, and capabilities significantly in the next year, we’re looking for passionate people to join our global team.

We are seeking a highly motivated individual to join us as a QA Technical Specialist – Methods 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, lwful 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.

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