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.
About the Role The QA Specialist is responsible for the day-to-day activities of the Pharmaceutical Quality Systems team. This role requires system expertise and business knowledge to act as point of contact and maintain deep understanding of the system and process functionality/improvements and how they apply locally and globally to the system(s). The position collaborates and establishes relationships with site-based customers and global colleagues and provides updates to leadership as requested. As system SME, assists with user management, user support, problem solving and system training.
What You'll Do • Supports QA for project deliverables in accordance with the governing processes, and procedures within the assigned Quality area
• Assesses the impact of system controls and process modifications and maintains oversight of change management processes
• Provides Quality/GMP oversight and approval of assigned area/systems and processes lifecycle documentation, including risk and impact
assessments, product, process and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation
plans, and validation summary reports
• Reviews and approves QA procedures for the validation approach and lifecycle documents as assigned
• Generates, reviews, and approves QA documentation, procedures, and processes for operational readiness objectives and QA support of assigned area/systems in cGMP regulated facility
• Ensures project and operational quality objectives are met within desired timelines
• Actively seeks opportunities to collaborate and align with other FUJIFILM Diosynth Biotechnologies sites to streamline processes and maximize efficiency
• Supports quality decisions that may impact operations, ensuring appropriate escalation
• Identifies risks and communicates gaps for quality and GMP process/systems
• Performs other duties, as assigned
Minimum Requirements: • BS/BA in Life Sciences or Engineering or equivalent with 3+ years of
applicable industry experience OR
• Masters in Life Sciences or Engineering with 0- 1 year of applicable
industry experience.
• Excellent oral and written communications skills and fluency in
English
Preferred Requirements: • Understanding of GAMP5, Data Integrity, and application of 21 CFR
Part 820 and Part 11
• Prior experience working within a QA role preferred
Physical and Work Environment Requirements: Ability to stand for prolonged periods of time up to 30 minutes
Ability to sit for prolonged periods of time up to 120 minutes.
Ability to conduct workthat includes moving objects up to 10 pounds.
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 . 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.
