Senior QA Technical Specialist (Manufacturing QA)

Overview

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.

External US

We are seeking a highly motivated Sr. QA Technical Specialist (Manufacturing QA) to function as a Quality Assurance SME, with limited supervision, in our Contract Manufacturing site located in Research Triangle Park, NC.

Primary responsibilities will be to support Manufacturing QA team responsible for monitoring Deviations, CAPAs, and Change Controls / management, performance of external audits / site inspections and readiness activities.

Successful candidate will have a proven track record of leading teams and collaborating cross-functionally. Experience with change management review boards is a plus.

MAJOR ACTIVITIES AND RESPONSIBILITIES

• Function as the site SME for Manufacturing QA matters. Can make decisions within the SOP, Standard practice, and regulatory framework for compliance areas in which they are an SME and can assist others in cross functional peer conflict resolution
• 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.

Can lead small cross-functional groups to investigate, recommend improvements to management, and monitor effectiveness of improvements for unique issues.

• 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
• Consistently demonstrates positive inclusive behaviors, consistently promotes positive team attitude, and supports business objectives

BACKGROUND 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,