QA Associate II (Document Control)

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 the Document Control team responsible for quality and compliance document processing, handling, and archival.

Primary responsibilities will be processing documents in the EDMS, filing GMP records, issuing documents as requested, and processing documents for offsite archival.

Essential Functions and Duties:

  • Process documents in the EDMS, review for conformance to the approved Templates, post for 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.
  • Maintain the document holding room by assisting with filing and organization of records
  • Support client and regulatory audits by retrieving requested records in a timely manner

Required Qualifications and Skills:

  • BS/BA and 2+ 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.
  • 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
  • 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

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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