Senior Specialist 2, QC LIMS

Position Overview

The Senior Specialist II, QC LIMS is a site-level and cross-functional leader for the Laboratory Information Management System (LIMS), operating with minimal oversight and in accordance with applicable regulatory, corporate, and scientific standards. This role architects, configures, validates, and governs the LIMS platform; plans and executes complex change initiatives; establishes and monitors system health and data integrity controls; and leads continuous improvement and expansion of LIMS capabilities.

The Senior Specialist II partners closely with Quality Control (QC), Analytical Development (AD), Manufacturing, Information Technology (IT), and Quality Assurance (QA) to ensure sustained compliance with Good Manufacturing Practice (GMP) requirements, robust data integrity, and business continuity.

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:

• Leads LIMS release and major enhancement initiatives, including planning, risk assessment, migration strategy for static and master data, configuration build, validation approach, cutover, and hypercare to ensure successful site adoption of Lab Ware LIMS v.8.
• Serves as the primary configuration architect for complex LIMS objects, including Specifications, Analyses, Batch Templates, Test Lists, Quality Control samples, Calculations and Format Calculations, and advanced templates (for example, Stability, Sample Login, Standards and Reagents), ensuring scalability, maintainability, and compliance.
• Governs the site change management process for LIMS, including impact assessment, approval, prioritization, and implementation of configuration updates to specifications, analyses, and other static data, ensuring alignment with controlled records and version control practices.
• Establishes and maintain system data integrity controls and monitoring (for example, audit trails, access management, segregation of duties, and periodic reviews); investigate and remediate data integrity issues; drive preventive actions.
• Designs, develops, and optimizes advanced queries and reporting solutions that deliver actionable insights, enable trending and metrics, and identify process gaps; implement and steward key performance indicators for LIMS usage, turnaround time, and data quality.
• Provides expert-tier user support, root-cause analysis, and problem resolution; triage and resolve complex incidents; implement permanent corrective and preventive actions; communicate changes and system impacts to stakeholders.
• Leads cross-functional collaboration with QC, AD, QA, Manufacturing, and IT to translate business needs into user and functional requirements; facilitate design workshops; ensure delivered solutions meet user requirements and compliance expectations.
• Authors, reviews, and approves LIMS documentation, including Standard Operating Procedures, Work Instructions, Design and Configuration Specifications, training materials, validation protocols, and requirement specifications; ensure documentation accurately reflects production configurations.
• Develops and delivers role-based training curricula and job aids; mentor and coach Specialists and end-users; elevate overall system proficiency and stewardship across the laboratory organization.
• Maintains and enhances LIMS integrations and interfaces (for example, instruments, chromatography data systems, enterprise resource planning, stability systems, and data visualization tools) in partnership with IT and vendors; ensure interface reliability and validated state.
• Leads audit and inspection readiness for LIMS; present system design, controls, validation evidence, and change records to internal and external auditors; address observations with timely, effective corrective and preventive actions.
• Champions continuous improvement by evaluating new LIMS capabilities, automation opportunities, and process simplification; propose and lead projects that reduce manual effort, cycle time, and compliance risk.
• Performs other…