QA Analyst - Digital Technologies

Overview

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are 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 manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

 

Join us

 

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.

External US

About This Role

 

The QA Analyst is responsible to assist in the Quality oversight of IT and Automation (OT) systems, bridging from site project/startup phase to operational readiness, as well as provide oversight of validation program execution for all GxP systems. The QA Analyst collaborates within the Digital Technologies (DT) Quality team as well as with other project teams on site, and with QA departments at other FDB sites with a focus on consistent policy administration, QA oversight of day-to-day activities and resolution or mitigation of issues occurring during operation.

 

What You’ll Do

• Supports QA for project deliverables in accordance with the governing processes, and procedures within the assigned Quality area (QA DT – IT/OT)
• Participates in assigned audits on regular basis
• Reviews and approves test plans and protocols for the validation approach and lifecycle documents
• Establishes and maintains a validation overview document of GxP IT Systems
• Assists with developing, reviewing, and revising standard operation procedures (SOPs)
• Assists with reviews and approval of validation deliverables (test results, defects/deviations and reports)
• Participates in risk assessments and assist in mitigating quality related risks
• Collaborates with entire Quality team, management, and other departments
• Other duties as assigned

Minimum Requirements:

• BA/BS in scientific discipline (e.g., Engineering, Applied Science or Chemistry)
• 0-2 years of Quality experience
• Understanding of GMP, GLP, GDP requirements

Preferred Requirements:

• Experience in a GxP pharmaceutical manufacturing environment and/or biopharma startup environment with QA Experience
• Digital Technologies experience (IT and/or Automation)

 

 

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 FDBN_PNC@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.