Specialist, Quality Control Instrumentation

FUJIFILM Healthcare Americas Corporation; Holly Springs (NC); On-site; USD 60,000 - 80,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC is seeking a QC Specialist, Instrumentation to support routine operation, maintenance, and lifecycle management of the QC instrumentation program. You will ensure data integrity and regulatory compliance while assisting with SOPs, deviations, and CAPAs.

You will work with cross-functional teams, coordinate with vendors, and provide guidance to end users on instrument operation. This role includes on-call and occasional weekend coverage as needed.

Qualifications

• Bachelor’s degree in a relevant scientific discipline (Chemistry, Biochemistry, Microbiology, Biology or Life Sciences).
• 0-3 years laboratory experience.
• Hands-on experience with analytical instrumentation including UPLC/HPLC, capillary electrophoresis, gel electrophoresis/Western blot, plate readers, qPCR, spectrophotometry, and mass spectrometry.

Responsibilities

• Supports 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 define user roles and privileges for data integrity and writes operation instructions and maintenance plans.
• Coordinates with vendors for QC instrument maintenance.
• Completes routine reviews of QC instruments and control software.
• Identifies and follows up on excursions and deviations and assists CAPAs.
• Provides support and guidance to stakeholders on QC instrumentation.
• Works cross-functionally with end users as needed.

Skills

MS Office

Cross-functional

Communication

Bio/pharma testing

Data integrity

Investigation & CAPA

Technical writing

Fast-paced environment

Education

Bachelor's in Life Sciences

Tools

UPLC/HPLC

Capillary electrophoresis

Gel electrophoresis/Western blot

Mass spectrometry

qPCR

Spectrophotometry

Plate readers

Kneat

Job description

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.

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

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 ([e-mail]).