Senior QA Technical Specialist

1 day ago


Durham, North Carolina, United States Fujifilm Corporation Full time

About the Role

Fujifilm Diosynth Biotechnologies is seeking a highly motivated Sr. QA Technical Specialist (Manufacturing QA) to join our team in Research Triangle Park, NC. As a Quality Assurance SME, you will be responsible for monitoring Deviations, CAPAs, and Change Controls/management, performance of external audits/site inspections and readiness activities.

Key Responsibilities

  • Function as the site SME for Manufacturing QA matters, making decisions within the SOP, Standard practice, and regulatory framework for compliance areas.
  • Provide On the Floor support for manufacturing operations.
  • Support Manufacturing QA (Deviation, CAPA, Change Management, inspection/audit readiness) projects, and staff to meet site quality and compliance expectations.
  • Well-developed problem solving skills to identify and solve problems within the SOP, Standard Practice, and regulatory framework.
  • Communicate cross functionally with peers, management, and external customers in oral, presentation, and written forms.
  • Represent Manufacturing QA for internal/external audits and regulatory inspections.
  • Provide highly collaborative, cross-functional support within the QA Organization.

Requirements

Minimum Education Requirements: BS/BA

Desired Experience: 8+ years of applicable QA experience in Biopharma

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. If an accommodation to the application process is needed, please contact us at [insert contact information].



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