QA Operations Specialist II

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

We are looking for a QA Operations Specialist II, Drug Substance Manufacturing (DSM), who wants to participate in our journey to establish the largest end-to-end cell culture CDMO facility in North America. More importantly, someone who wants to be a part of the largest growth journey that we in FUJIFILM have ever entered. As the QA Operations Specialist II DSM, you will directly impact the validation and start-up of a fully automated $2 billion Greenfield CDMO facility.

During the project phase, the QA Operations Specialist II for DSM will be responsible to partner in the Quality oversight of Drug Substance Manufacturing processes through to operational readiness, as well as provide oversight of validation program execution for these processes. You will collaborate within the DSM Quality team as well as with other project teams, and with QA departments at other sites to align strategies and procedures.

Once in operations, you will continue to ensure that applicable DSM systems and processes are operated/maintained in a validated state throughout their lifecycle, with a focus on consistent policy administration, QA oversight of day-to-day activities and resolution or mitigation of issues occurring during operation. Additionally, you may participate in optimization or improvement initiatives and support regulatory agency and third-party inspections.

You will report to the QA Lead Engineer for DSM

External US

• Provide QA oversight and support of project deliverables in accordance with governing processes, and procedures for the DSM program
• Assess the impact of system and process modifications and maintain oversight of change management processes to ensure Manufacturing Systems are first validated and then maintained in a validated state through startup and into commercial operation
• Provide oversight and approval of system and process lifecycle documentation, including risk and impact assessments, product, process and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports.
• Contribute to the development of QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility
• Ensure that project and operational quality objectives are met within desired timelines.
• Participate in streamlining or efficiency improvement initiatives with other FUJIFILM Diosynth Biotechnologies sites.
• This role and the associated responsibilities will develop as the project matures, and startup activities evolve into operations

Requirements

We are looking for a candidate with the following background and skill sets:

• Collaborative attitude with the willingness to work with global peers and cross-functional teams toward company and department goals
• Education and experience appropriate to a specialist level role in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility, is required. A minimum of 2 years' experience in a quality role is required.
• Excellent oral and written communications skills and fluency in English
• Working knowledge of ASTM E2500, Smartsheet and/or Kneat validation software is a plus
• Familiarity/understanding of validation of production equipment, hygienic utilities, quality systems, automation, manufacturing & IT Systems, and methodologies is a plus
• Understanding of GAMP5, Data Integrity, and application of 21 CFR Part 820 and Part 11 is a plus
• Understanding of one or more of the following processes is a plus:
  • cell culture or fermentation
  • large-scale recovery processes
  • formulation and/or fill
  • finished goods manufacturing
• Occasional opportunity for International and/or Domestic travel may be available
• Training and/or familiarity with Quality Risk Management principles is a plus

The Company requires that the successful candidate hired for this position be fully vaccinated for COVID-19, absent being granted an accommodation due to medical, pregnancy, or sincerely held religious belief or other legally required exemption.

FDBN 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.

FDBN 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 email lena.lee@fujifilm.com.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any  kind will be paid.