FUJIFILM Biotechnologies
QA Specialist, PQS
FUJIFILM Biotechnologies, Holly Springs, North Carolina, United States, 27540
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QA Specialist, PQS
role at
FUJIFILM Biotechnologies .
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.”
Job Description What You’ll Do
Supports QA for project deliverables in accordance with the governing processes, and procedures within the assigned Quality area
Assesses the impact of system controls and process modifications and maintains oversight of change management processes
Provides Quality/GMP oversight and approval of assigned area/systems and processes lifecycle documentation, including risk and impact assessments, product, process and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports
Reviews and approves QA procedures for the validation approach and lifecycle documents as assigned
Generates, reviews, and approves QA documentation, procedures, and processes for operational readiness objectives and QA support of assigned area/systems in cGMP regulated facility
Ensures project and operational quality objectives are met within desired timelines
Actively seeks opportunities to collaborate and align with other FUJIFILM Diosynth Biotechnologies sites to streamline processes and maximize efficiency
Supports quality decisions that may impact operations, ensuring appropriate escalation
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 industry experience OR
Masters in Life Sciences or Engineering with 0 years of applicable industry experience.
1-3 years of experience in a GMP environment
Preferred Requirements
Prior experience working within a QA role preferred
Working Conditions & Physical Requirements
Will work in environment which may necessitate respiratory protection X No Yes
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes
Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes
Ability to discern audible cues. No x Yes
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. X No Yes
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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QA Specialist, PQS
role at
FUJIFILM Biotechnologies .
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.”
Job Description What You’ll Do
Supports QA for project deliverables in accordance with the governing processes, and procedures within the assigned Quality area
Assesses the impact of system controls and process modifications and maintains oversight of change management processes
Provides Quality/GMP oversight and approval of assigned area/systems and processes lifecycle documentation, including risk and impact assessments, product, process and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports
Reviews and approves QA procedures for the validation approach and lifecycle documents as assigned
Generates, reviews, and approves QA documentation, procedures, and processes for operational readiness objectives and QA support of assigned area/systems in cGMP regulated facility
Ensures project and operational quality objectives are met within desired timelines
Actively seeks opportunities to collaborate and align with other FUJIFILM Diosynth Biotechnologies sites to streamline processes and maximize efficiency
Supports quality decisions that may impact operations, ensuring appropriate escalation
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 industry experience OR
Masters in Life Sciences or Engineering with 0 years of applicable industry experience.
1-3 years of experience in a GMP environment
Preferred Requirements
Prior experience working within a QA role preferred
Working Conditions & Physical Requirements
Will work in environment which may necessitate respiratory protection X No Yes
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes
Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes
Ability to discern audible cues. No x Yes
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. X No Yes
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