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Senior Specialist 2, Quality Control Instrumentation
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Other
bachelor degree, postgraduate degree
Posted 18d ago
Apply by Jul 24
~40 hrs/week
Responsibilities
Lead the lifecycle management of QC analytical instrumentation, including qualification, routine operation, maintenance, and decommissioning. Ensure strict adherence to regulatory guidelines and data integrity standards while partnering with cross-functional teams and external vendors.
Requirements
Requires a degree in Chemistry, Biochemistry, Engineering, or a related science field with experience ranging from 1 to 5+ years depending on the degree level. Must have at least 3 years of experience in a GMP environment and hands-on expertise with various analytical instruments.
Full job description
Position 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.
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
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.
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
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 ([email protected]).
FUJIFILM Electronic Materials supplies the world's top tier semiconductor manufacturers with a broad array of products.
Industry
Chemical Manufacturing
Company size
501-1,000 employees
Headquarters
North Kingstown, RI
LinkedIn followers
8,951
FUJIFILM Electronic Materials develops and manages chemical formulations that power the most critical processes of semiconductor technology. We are a diverse, global supplier that delivers tailored support where our customers need us most. The spirit of partnership drives everything we do — our commitment to the continued success and innovation of our customers is our primary focus. Through state-of-the-art systems, leading-edge technologies, and a commitment to the continuous development of environmentally friendly processes, FUJIFILM Electronic Materials is:
DEDICATED — to the success of our customers and team
CURIOUS — with a genuine interest in finding new ways to innovate
DRIVEN — motivated to push the boundaries of possibility
COLLABORATIVE — committed to working jointly to develop the best solutions
Headquartered in Yokohama, Japan, FUJIFILM Electronic Materials has 11 regional offices globally. As proud members of the FUJIFILM Group, we are one of the leading and most trusted producers of the chemical formulations that enable our partners to progress semiconductor technology to the next node and beyond. Our assured, stable supply is proven through our state-of-the-art quality system. Leveraging leading-edge technologies, our formulations help to power cell phones, computers, medical devices, cars, refrigerators and other goods essential to human life.
The engineers, scientists, manufacturing staff and other professionals who commit their skills and intellect to FUJIFILM Electronic Materials strive to make a difference in their jobs and in the world. Our organization offers the opportunity to pursue challenging and meaningful work in an environment that supports growth. With an internal culture that prioritizes teamwork, open communication and shared success, FUJIFILM Electronic Materials inspires both personal and customer advancement.
Offices: 80 Circuit Drive, North Kingstown, RI 02852, US · 6550 South Mountain Road, Mesa, AZ 85212, US · 1200 W Jackson Rd, Carrollton, Texas 75006, US · 1160 Commercial Pkwy, Castroville, California 95012, US · 250 William White Blvd, Pueblo, Colorado 81001, US
CMP SlurriesCleaners and EtchantsCVD PrecursorsPhotoresistsImage Sensor Color MosaicPhotoresist AncillariesPolyimides and PBO'sHigh Purity Primary SolventsPhotovoltaic Precursorsand Photovoltaic Precursor Equipment
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