Fujifilm Diosynth Biotechnologies

Position Overview

The QA Specialist, Supplier Quality is responsible for the day-to-day activities of administering Supplier Quality activities. This role acts as a point of contact for supplier quality and maintains supplier quality agreements, familiarity with audit programs, and vendor management processes. The QA Specialist, Supplier Quality administers approved supplier lists for the Holly Springs, NC site. This role collaborates internally with multiple QA teams, including Supplier Quality and site-based customers Supply Chain teams to manage and provide updates to suppliers.

Company Overview

FUJIFILM Diosynth 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: https://www.fujifilm.com/us/en/about/region/careers

Job Description

What You'll Do

• Acts as workflow Subject Matter Expert (SME) for supplier management, assists the team with system updates, user support, problem solving and system training
• Supports QA Supplier Quality with governing processes and procedures within supplier management area
• Maintains oversight of TrackWise workflow for supplier management including quality agreement, vendor management, vendor changes and supplier complaints
• Drives timely closure for Quality metrics within Supplier Quality through dashboards and involves relevant team members, stakeholders, and external partners to ensure compliance and timely progress for records
• Authors and reviews QA procedures for supplier quality and Supply Chain areas, as assigned
• Ensures project and operational quality objectives are met within desired timelines
• Collaborates and aligns with other FUJIFILM Diosynth Biotechnologies sites to streamline processes and maximize efficiency within area of responsibility
• Assists with and supports operational quality decisions and ensures proper escalation when necessary
• 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 2+ years of applicable experience OR
• Master’s in Life Sciences or Engineering or equivalent with 0 years of applicable experience OR
• 1-3 years’ experience in a GMP environment

Preferred Requirements:

• Experience working within a QA role
• Experience with TrackWise

Physical and Work Environment Requirements:

Ability to discern audible cues.

Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.

Ability to ascend or descend ladders, scaffolding, ramps, etc.

Ability to stand for prolonged periods of time up to 60 minutes.

Ability to sit for prolonged periods of time up to 120 minutes.

Ability to conduct activities using repetitive motions that include writs, hands and/or fingers.

Ability to conduct work that includes moving objects up to 10 pounds.

Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions.

Will work in small and/or enclosed spaces.

Will work in heights greater than 4 feet.

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.

• #LI-Onsite

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).