QA Specialist, DSM (0600-1800/2-2-3)

Position Overview

The QA Specialist, Operations (Days 2-2-3 0600-1800) 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.

Company Overview

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:

Job Description

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
o Batch Record and Solution Lot Record review, including exception-based oversight using Quality Review Management tool
o Real time event triage and implementation of immediate response to identified deviations
o Area changeover and return to service
o 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

Minimum Requirements:

• 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

Preferred Requirements:

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

Working Conditions & Physical Requirements:

• 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 writs, hands and/or fingers
• Ability to conduct work that includes moving objects up to 10 pounds

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.

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 ([email protected]).