Position Overview

The Quality Control Senior Specialist 1, Instrumentation works independently to perform routine operations, continuous improvement, and life-cycle management of the QC analytical instrumentation program. This role ensures compliance of QC analytical instrumentation with Data Integrity standards in accordance with regulatory guidelines and company policies and procedures. This role ensures the performance of routine maintenance, completing periodic reviews of QC analytical instrumentation to confirm compliance and correct deviations and excursions. The role supports stakeholders with issues and guidance related to QC analytical instruments. This role is included in routine on-call and weekend support, as needed.

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: https://www.fujifilm.com/us/en/about/region/careers

Job Description

Responsibilities:

• Leads the execution of the qualification, maintenance, continuous improvement, and decommissioning of QC analytical instrumentation, applying expertise in instrumentation, validation, and regulatory compliance
• Ensures all QC equipment and instruments adhere to regulatory guidelines and site policies
• Authors and critically evaluates SOPs, technical reports, user requirements, functional specifications, and KNEAT protocols and reports, employing advanced scientific expertise to ensure accuracy, comprehensiveness, and regulatory alignment
• Champions data integrity initiatives related to analytical instruments, deploying specialized analytical skills to safeguard data reliability and compliance
• Reviews and recommends appropriate user roles and privileges for data integrity (where applicable), writes instrument operation instructions and preventative maintenance plans
• Coordinates with vendors, leveraging scientific insight to ensure effective maintenance and performance of analytical instruments
• Completes periodic reviews of QC instruments and associated instrument control software
• Proactively identifies and addresses excursions and deviations, initiating effective corrective and preventative actions (CAPAs) using independent judgment to maintain instrument integrity and compliance
• Supports stakeholders, including end users, with issues and guidance related to QC analytical instruments
• Works cross functionally with all end users, Validation Team, Labware Specialists, and Quality Assurance
• Performs other duties, as assigned

Education/Experience Requirements:

• Bachelor’s degree in Science, preferably Chemistry, Biochemistry, Microbiology, Biology, or Life Sciences relevant scientific discipline with 2+ years of relevant experience OR
• Master’s degree in science, preferably Chemistry, Biochemistry, Microbiology, Biology, or Life Sciences relevant scientific discipline with 0 years’ of relevant experience
• 3 years’ relevant experience, experience in a GMP environment
• Hands on experience with analytical instrumentation associated with the following technologies: UPLC/HPLC, capillary
• electrophoresis/imaged capillary isoelectric focusing, gel electrophoresis/Western blot, plate readers, qPCR, spectrophotometry, and mass spectrometry.

Preferred Requirements:

• Experience with KNEAT software
• Experience qualifying analytical instruments

Working Conditions/Physical Requirements:

• Ability to discern audible cues
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color
• Ability to ascend or descend ladders, scaffolding, ramps, etc
• Ability to stand for prolonged periods of time, up to 60 minutes
• Ability to sit for prolonged periods of time, up to 60 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
• Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and using twisting motions
• Will work in small and/or enclosed spaces
• Will work in heights greater than 4 feet

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.

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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]).