• QA Specialist, Operations (Night)

    Fujifilm (Holly Springs, NC)


    Position Overview

    The QA Specialist, Operations (Nights) is responsible for partnering in the Quality oversight of Drug Substance Manufacturing processes for 12-hour overnight shift. This role collaborates within the DSM Quality team as well as with other cross-functional teams. Ensures that applicable DSM systems and processes are operated/maintained as intended, with a focus on consistent policy administration, QA oversight of activities occurring during the shift and resolution or mitigation of issues occurring during operation.

     

    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

    • Under the direction of Supervisor, provides QA oversight on the 12-hour overnight shift (6:00pm - 6:00am [2-2-3]) and supports DSM operations in accordance with governing processes and procedures

    • Provides QA support of DSM to include:

    a. Batch Record and Solution Lot Record review, including exception-based oversight using Quality Review Management tool

    b. Real time event triage and implementation of immediate response to identified deviations

    c. Area changeover and return to service

    d. Real time WO oversight per applicable procedures

    • Ensures department objectives are met within desired timelines and/or in accordance with identified KPIs

    • Contributes to the development of QA documentation, procedures, and processes for operational readiness objectives and QA support of

    manufacturing operations in cGMP regulated facility

    • Performs 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

    Physical and Work Environment Requirements:

    Ability to discern audible cues.

     

    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 wrists, 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]).

     

    **Job Locations** _US-NC-Holly Springs_

    **Posted Date** _2 months ago_ _(3/26/2025 4:12 PM)_

    **_Requisition ID_** _2025-34019_

    **_Category_** _Quality Assurance_

    **_Company (Portal Searching)_** _FUJIFILM Diosynth Biotechnologies_