Sr. Specialist 1, QC Instrumentation

Fujifilm•Holly Springs, NC

12d

About The Position

The QC Sr. 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. 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.”

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
1- 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.

Nice To Haves

Experience with KNEAT software
Experience qualifying analytical instruments

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