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QA Associate III (Doc Control)

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.

 

Essential Functions and Duties:

  • Process documents in the EDMS, review for conformance to the approved Templates, coordinate with end-users to obtain client approval, and coordinate with end-users to assign the document Effective Date.
  • Become an SME for the EDMS, to assist end-users with task tracking and finding documents.
  • Issue paper records such as Batch Records and Logbooks in a timely manner, following approved procedures.
  • Assist with filing and organization of records in the document holding room
  • Support client and regulatory audits by retrieving requested records in a timely manner

Required Qualifications and Skills:

  • BS/BA and 4+ years in a regulated organization; Document Control role is preferred

Desired Qualifications and Skills:

  • Experience working in MasterControl EDMS (or other electronic document management system) – basic user navigation, workflow tasks, creating/revising documents, etc.
  • Strong orientation for quality and customer service
  • Strong organizational skills (e.g., tracking deadlines, managing multiple documents)
  • Able to work independently with moderate supervision, including ability to escalate appropriately
  • Ability to effectively communicate both verbally and in writing to convey clear, well-articulated information with all level of personnel
  • Intermediate skills in Microsoft Word (e.g., formatting headers, footers, outline style, tables)
  • Basic skills in Microsoft Excel (e.g., formatting, sorting data)
  • Experience with Google sheets and documents is desired

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.

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