QA Specialist, DSM

QA Specialist, DSM (2-2-3 Days)

Job Location s: US-NC-Holly Springs

Posted Date: 20 hours ago (1/5/2026 12:27 PM)

Requisition :

Category:
Quality Assurance

Company: FUJIFILM Biotechnologies

The QA Specialist, Operations (2-2-3 Day ) is responsible for partnering in the Quality oversight of Drug Substance Manufacturing processes. This role provides oversight of validation program execution for these processes and systems to ensure applicable DSM systems and processes are operated/maintained in a validated state throughout their lifecycle, with a focus on consistent policy administration. The QA Specialist, Operations ensures QA oversight of day‑to‑day activities and resolution or mitigation of issues occurring during operation.

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:

What You’ll Do

• Provides QA oversight and supports DSM operations in accordance with governing processes and procedures.
• Provides QA support of DSM tasks such as:
  • Batch Record and Solution Lot Record review, including exception‑based oversight using Quality Review Management tool.
  • Real‑time event triage and implementation of immediate response to identified deviations.
  • Area changeover and return to service.
  • Real‑time WO oversight per applicable procedures.
• Ensures department objectives are met within desired timelines and/or in accordance with identified KPIs.
• Contribute to the development of QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility.
• Participate in streamlining or efficiency improvement initiatives with other FUJIFILM Diosynth Biotechnologies sites.

Works 12‑hour shift on 2‑2‑3 cadence, 0600‑1800

Perform other duties, as assigned.

• BS/BA in Life Sciences or Engineering or equivalent with 2+ years of relevant experience OR
• Masters in Life Sciences or Engineering or equivalent with 0 years’ relevant experience
• 1‑3 years’ experience in a GMP environment
• Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility

• 2+ years of experience in GMP Quality Assurance and/or similar role
• Experience and working knowledge of ASTM E2500, Smartsheet, Trackwise, Master Control and/or Kneat validation software

• Ability to discern audible cues
• 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 activities using repetitive motions that include writes, hands and/or fingers
• Ability to conduct work that includes moving objects up to 10 pounds

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.

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 ().