Specialist, Quality Control Instrumentation

Fujifilm•Holly Springs, NC

2d•Onsite

About The Position

The QC Specialist, Instrumentation works under the direction of senior team members to support routine operations, continuous improvement, and life-cycle management of the QC analytical instrumentation program. This role helps ensure compliance with Data Integrity standards, following regulatory guidelines and company procedures. The Specialist assists with routine maintenance, conducts periodic reviews of QC analytical instruments, and helps identify and address deviations or issues. The position also involves providing support for on-call and weekend coverage when 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.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Requirements

Working knowledge and experience in Microsoft Office products (Outlook, Word, Excel, and Power Point).
Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships.
Excellent verbal and written communication skills and attention to detail.
Thorough understanding of the pharmaceutical/biotech testing.
Proven ability to understand and implement data integrity standard and regulations.
Proven ability to conduct investigations, writing deviations and CAPA’s.
Superior technical writing and problem-solving skills required.
The ability to effectively communicate and function in a fast-paced, highly technical environment is essential to success.
Bachelor’s in relevant scientific discipline, preferably Chemistry, Biochemistry, Microbiology, Biology or Life Sciences
0-3 years laboratory experience
Prior 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

GMP laboratory experience
Experience with Kneat software.
Experience qualifying analytical instruments

Responsibilities

Supports the qualification, routine operation, maintenance, and decommissioning of QC analytical instruments.
Ensures QC equipment and instruments adhere to regulatory guidelines and site policies.
Assists in drafting and reviewing SOPs, technical reports, user requirements, and maintenance documentation.
Participates in data integrity initiatives related to analytical instruments.
Helps recommend appropriate user roles and privileges for data integrity and assists in writing operation instructions and preventative maintenance plans.
Coordinates with vendors for maintenance activities on QC instruments.
Completes routine periodic reviews of QC instruments and their control software.
Identifies, reports, and follows up on excursions and deviations and assists in corrective and preventative actions (CAPAs).
Provides support and guidance to stakeholders, including end users, on QC analytical instrumentation.
Works cross-functionally with all end users as needed.