Senior Specialist 2, Quality Control Instrumentation

NCBiotech; Holly Springs (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

Fujifilm Biotechnologies in Holly Springs, NC seeks a Sr. Specialist 2, QC Instrumentation, to own the lifecycle of QC analytical instruments.

You will lead qualification, operation, maintenance, and decommissioning with minimal supervision, ensuring data integrity and regulatory compliance across functions and with external vendors. The role requires extensive hands-on experience with analytical instrumentation (UPLC/HPLC, iCIEF, Western Blot, qPCR, Mass Spec) and a GMP background.

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Biological Sciences, Engineering, or related field with 5+ years GMP experience.
• Master’s degree in Chemistry, Biochemistry, Biological Sciences, Engineering, or related field with 3+ years GMP experience.
• PhD in Chemistry, Biochemistry, Biological Sciences, Engineering, or related field with 1+ years GMP experience.
• 3+ years of experience in a GMP environment.
• Hands-on experience with analytical instrumentation including UPLC/HPLC, Capillary Electrophoresis/iCIEF, Gel Electrophoresis/Western Blot, Plate Readers, qPCR, Spectrophotometry, and Mass Spectrometry

Responsibilities

• Manage the qualification, routine operation, maintenance, continuous improvement, and decommissioning of QC analytical instrumentation.
• Ensure QC equipment and instruments adhere to applicable regulatory guidelines, data integrity expectations, and site policies.
• Develop, author, and review SOPs, technical reports, user requirements, functional specifications, and KNEAT protocols and reports.
• Lead data integrity initiatives for analytical instruments, including periodic reviews to ensure ongoing compliance.
• Recommend user roles and privileges to uphold data integrity; design instrument operating instructions and preventive maintenance plans.
• Execute and evaluate periodic reviews of QC instruments and their control software; monitor ongoing performance and drive process improvements.
• Partner with vendors to plan and oversee instrument maintenance activities.
• Initiate and oversee follow‑up on excursions and deviations; manage CAPAs related to analytical instruments.
• Provide guidance to stakeholders and address issues related to QC analytical instruments; manage a variety of routine tasks while balancing project priorities.
• Collaborate with cross‑functional partners including end users, Validation, Labware Specialists, and Quality Assurance to ensure effective, compliant instrument operations.
• Perform other duties, as assigned.

Skills

GMP experience

Analytical instrumentation

Cross-functional collaboration

Education

Bachelor’s in Chemistry/Bio sciences/Engineering

Master’s in Chemistry/Bio sciences/Engineering

PhD in Chemistry/Bio sciences/Engineering

Tools

UPLC/HPLC

Capillary Electrophoresis/iCIEF

Gel Electrophoresis/Western Blot

Plate Readers

qPCR

Spectrophotometry

Mass Spectrometry

Job description

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 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

Overview

Join a high‑impact Quality Control team where you’ll own the lifecycle of critical analytical instruments that keep life‑changing therapies moving. As Sr. Specialist 2, QC Instrumentation, you will lead the routine operation, qualification, maintenance, continuous improvement, and decommissioning of QC analytical instrumentation with minimal supervision while ensuring data integrity and regulatory compliance at every step. You’ll be the go‑to expert for instrument performance and reliability, partnering across functions and with external vendors to solve complex problems, drive process improvements, and uphold world‑class standards. This role includes periodic on‑call and weekend support as needed.

What you’ll do

• Manage the qualification, routine operation, maintenance, continuous improvement, and decommissioning of QC analytical instrumentation.
• Ensure QC equipment and instruments adhere to applicable regulatory guidelines, data integrity expectations, and site policies.
• Develop, author, and review SOPs, technical reports, user requirements, functional specifications, and KNEAT protocols and reports.
• Lead data integrity initiatives for analytical instruments, including periodic reviews to ensure ongoing compliance.
• Recommend user roles and privileges to uphold data integrity; design instrument operating instructions and preventive maintenance plans.
• Execute and evaluate periodic reviews of QC instruments and their control software; monitor ongoing performance and drive process improvements.
• Partner with vendors to plan and oversee instrument maintenance activities.
• Initiate and oversee follow‑up on excursions and deviations; manage corrective and preventive actions (CAPAs) related to analytical instruments.
• Provide guidance to stakeholders and address issues related to QC analytical instruments; manage a variety of routine tasks while balancing project priorities.
• Collaborate with cross‑functional partners—including end users, Validation, Labware Specialists, and Quality Assurance—to ensure effective, compliant instrument operations.
• Perform other duties, as assigned.

How you’ll work

• Tackle problems of diverse scope, analyzing limited information and precedent to devise solutions and adapt approaches.
• Apply sound evaluation, judgment, and interpretation to select the right course of action.
• Operate independently with work reviewed at critical points.
• Build strong relationships and networks with senior internal/external partners—often advising others on complex topics and tailoring communication to differing audiences.

Minimum education and experience requirements

• Bachelor’s in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 5+ years of experience OR
• Master’s in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 3+ years of experience OR
• PhD in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 1+ years of experience
• 3+ years of experience in a GMP environment
• Prior hands‑on experience with analytical instrumentation, including but not limited 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, and Mass Spectrometry

Preferred qualifications

• 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)

Why this role

• Own a mission‑critical instrument program and make measurable impact on data integrity, compliance, and QC reliability.
• Shape best practices, steward continuous improvement, and partner across the organization and with external vendors.
• Develop as a trusted advisor who solves complex challenges and advances operational excellence.

Work schedule

• Includes periodic on‑call and weekend support, as needed.

Ready to lead the instruments that power high‑quality science? Apply now.

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 ([e-mail]).