Specialist, Quality Control Instrumentation

Position Overview 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. Job Description Major Accountabilities: 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. Knowledge, Skills and Abilities: 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. Education and Experience Requirements: 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. Preferred Education and Experience: GMP laboratory experience Experience with Kneat software. Experience qualifying analytical instruments Physical Requirements: Ability to discern audible cues. Ability to inspect or perform a task with 20/20 corrected vision, including distinguishing color. Ability to stand for up to 60 minutes. Ability to sit for up to 60 minutes. Ability to conduct activities using repetitive motions that includes wrists, 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 use twisting motions. Will work in small and/or enclosed spaces. Will work in heights greater than four feet. 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 (View email address on click.appcast.io). #J-18808-Ljbffr FUJIFILM Holdings America Corporation