FUJIFILM Biotechnologies
QA Specialist, DSM (2-2-3 Days)
FUJIFILM Biotechnologies, Holly Springs, North Carolina, United States, 27540
QA Specialist, DSM (2-2-3 Days) – FUJIFILM Biotechnologies
Company Overview
FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By the 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 vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and a culture that fuels 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. The Group Purpose is "giving our world more smiles".
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 batch record and solution lot record review, including exception‑based oversight using the 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.
Contributes to the development of QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in a cGMP regulated facility.
Participates in streamlining or efficiency improvement initiatives with other FUJIFILM Diosynth Biotechnologies sites.
Works a 12‑hour shift on a 2‑2‑3 cadence, 0600‑1800.
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 a 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 writes, hands and/or fingers.
Ability to move objects up to 10 pounds.
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).
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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. The Group Purpose is "giving our world more smiles".
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 batch record and solution lot record review, including exception‑based oversight using the 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.
Contributes to the development of QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in a cGMP regulated facility.
Participates in streamlining or efficiency improvement initiatives with other FUJIFILM Diosynth Biotechnologies sites.
Works a 12‑hour shift on a 2‑2‑3 cadence, 0600‑1800.
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 a 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 writes, hands and/or fingers.
Ability to move objects up to 10 pounds.
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).
#J-18808-Ljbffr