Senior Specialist 1, Quality Control Instrumentation

Fujifilm•Holly Springs, NC

15d•Onsite

About The Position

As a Sr. Specialist I, QC Instrumentation, you will independently own the life cycle of QC analytical instruments—from qualification to decommissioning—ensuring they operate flawlessly, meet data integrity expectations, and stay in full compliance with regulatory requirements. This role is for individuals passionate about elevating lab performance, partnering cross-functionally, and solving complex instrumentation challenges. This position may require routine on-call and weekend support as needed.

Requirements

Bachelor’s degree in a science discipline (preferably Chemistry, Biochemistry, Microbiology, Biology, or Life Sciences) with 2+ years of relevant experience; OR Master’s degree in a science discipline (preferably Chemistry, Biochemistry, Microbiology, Biology, or Life Sciences) with 0 years of relevant experience.
1–3 years of relevant experience, including experience in a GMP environment.
Proficient with Microsoft Office (Outlook, Word, Excel, PowerPoint).
Strong cross-functional collaboration skills and the ability to build effective partnerships.
Excellent verbal and written communication with exceptional attention to detail.
Thorough understanding of pharmaceutical/biotech testing.
Proven ability to interpret and implement data integrity standards and regulations.
Demonstrated experience conducting investigations and writing deviations and CAPAs.
Superior technical writing and problem-solving skills.
Comfortable thriving in a fast-paced, highly technical environment.
Ability to perform routine on-call and weekend support, as needed.

Nice To Haves

Hands-on experience with analytical instrumentation such as: UPLC/HPLC, Capillary electrophoresis/imaged capillary isoelectric focusing, Gel electrophoresis/Western blot, Plate readers, qPCR, Spectrophotometry, Mass spectrometry
Experience with KNEAT software.
Experience qualifying analytical instruments.

Responsibilities

Lead the execution of qualification, maintenance, continuous improvement, and decommissioning of QC analytical instruments, applying deep expertise in instrumentation, validation, and regulatory compliance.
Ensure all QC equipment and instruments adhere to regulatory guidelines and site policies.
Author and critically evaluate SOPs, technical reports, user requirements, functional specifications, and KNEAT protocols and reports to ensure accuracy, completeness, and regulatory alignment.
Champion data integrity initiatives for analytical instruments, safeguarding data reliability and compliance.
Review and recommend appropriate user roles and privileges for data integrity (where applicable); write instrument operation instructions and preventive maintenance plans.
Coordinate with vendors to ensure effective maintenance and optimal performance of analytical instruments.
Complete periodic reviews of QC instruments and associated instrument control software.
Proactively identify and address excursions and deviations; initiate effective CAPAs to maintain instrument integrity and compliance.
Support stakeholders and end users with issue resolution and expert guidance related to QC analytical instruments.
Work cross-functionally with end users, the Validation team, Labware Specialists, and Quality Assurance.
Perform other duties, as assigned.