Senior Specialist 2, Quality Control Instrumentation (6/1)

Fujifilm•Holly Springs, NC

11d•Onsite

About The Position

The Senior Specialist 2, Quality Control Instrumentation manages routine operations, continuous improvement, and life-cycle management of the QC analytical instrumentation program with minimal supervision. This role ensures compliance with Data Integrity standards in alignment with regulatory guidelines and company policies. The Sr. Specialist executes and monitors the performance of routine maintenance, performs periodic reviews to ensure continued compliance, and leads the identification and correction of deviations. The role provides guidance to stakeholders and addresses issues related to QC analytical instruments. It also includes periodic 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

Requirements

Bachelor’s in chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 6+ years of analytical laboratory experience preferably in biotechnology, Pharma, Contract Research Organization (CRO), or Contract Laboratory Organization (CLO) OR
Master’s in chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 3+ years of experience, OR
1-3 years’ experience in a GMP environment
Prior Hands-on experience with analytical instrumentation, including but not limit to UPLC/HPLC (Ultra/High-Performance Liquid Chromatography), Capillary Electrophoresis/Imaged Capillary Isoelectric Focusing (iCIEF), Gel Electrophoresis/Western Blot, Plate Readers, qPCR (Quantitative Polymerase Chain Reaction), Spectrophotometry, Mass Spectrometry.
Experience using quality systems (e.g., deviation management system, change control, corrective and preventive action (CAPA), document management system

Nice To Haves

Experience qualifying analytical instruments.
Experience with Customer Relationship Management
Experience using quality systems (e.g., deviation management system, change control, corrective and preventive action (CAPA), document management system)

Responsibilities

Manages the qualification, routine operation, maintenance, continuous improvement, and decommissioning of QC analytical instrumentation.
Ensures QC equipment and instruments are adhered to regulatory guidelines and site policies.
Develops, authors, and reviews SOPs, technical reports, user requirements, functional specifications, and KNEAT protocols and reports.
Leads data integrity initiatives for analytical instruments.
Recommends user roles and privileges for data integrity and designs instrument operation instructions and preventative maintenance plans.
Partners with vendors to oversee maintenance activities for QC analytical instruments.
Executes and evaluates periodic reviews of QC instruments and their control software.
Initiates and oversees follow-up on excursions and deviations and manages corrective and preventative actions (CAPAs) related to analytical instruments.
Partners with cross-functional teams, including end users, Validation, Labware Specialists, and Quality Assurance, to ensure QC instrumentation operates effectively.
Monitors ongoing performance and drives improvements to QC instrumentation processes.
Manages a variety of routine tasks while effectively addressing complex situations as they arise.
Performs other duties as assigned.