QA Specialist, PQS

Position Overview

The QA Specialist, PQS 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 role collaborates and establishes relationships with site-based customers and global colleagues and provides updates to leadership as requested.

As a system SME, the QA Specialist, PQS assists with user management, user support, problem solving and system training.

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit:

• 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

• BS/BA in Life Sciences or Engineering or equivalent with 2+ years of applicable industry experience OR
• Masters in Life Sciences or Engineering with 0 years of applicable industry experience.
• 1-3 years of experience in a GMP environment

• Prior experience working within a QA role preferred

• Will work in environment which may necessitate respiratory protection X No Yes
• May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes
• Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes
• Ability to discern audible cues. No x Yes
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. X No Yes

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…