Senior Specialist 1, Quality Control LIMS

Fujifilm • Holly Springs, NC

12d • Onsite

About The Position

Help build and optimize a best-in-class LabWare LIMS v8 environment that powers Quality Control in a GMP setting. As Sr. Specialist 1, QC LIMS, you’ll configure, validate, and sustain a critical system that enables compliant, efficient testing—directly impacting product quality and patient safety.

Requirements

• Bachelor’s degree in Computer Science, Information Technology, Biology, Microbiology, Biochemistry, or a related scientific discipline with 2+ years of experience; or Master’s degree in the same fields with 0 years of experience
• Ability to function in a fast-paced, highly technical environment
• Demonstrated ability to work cross-functionally and build strong partnerships across levels (management, laboratory personnel, plant personnel)
• Thorough knowledge of cGMP/ICH/FDA regulations; familiarity with 21 CFR Part 11 and GAMP
• Strong verbal and written communication, technical writing, and problem-solving skills
• Understanding of pharmaceutical/biotech testing cycles or requirements
• Ability to work effectively with diverse teams

Nice To Haves

• 1–3 years of experience in a cGMP Quality Control department or FDA-regulated industry (drugs/biologics)
• Previous experience with LabWare LIMS development or other LIMS software development
• Experience with 21 CFR Part 11 and GAMP (applied/working experience)
• TrackWise (or similar quality system) experience for at least 1 year
• Leadership aptitude

Responsibilities

• Participate in the LabWare LIMS v8 site go-live, including static data migration, configuration, validation, and cross-functional coordination to ensure a successful rollout.
• Collaborate with business subject matter experts to define and document new or revised LabWare requirements.
• Configure basic and advanced LabWare LIMS objects, including: Specifications, Analyses, Batch Templates, Test Lists, QC Samples, Calculations, Format Calculations, Templates (Stability, Sample Login, Standards, Reagents).
• Execute qualification/verification testing to support implementation of new or revised LabWare configurations.
• Maintain and, when needed, repair configuration objects within LabWare LIMS.
• Create queries to support evolving business requirements.
• Use the change management system to update configurations for specifications, analyses, and other static data in LIMS.
• Provide timely user support and troubleshooting; create new configuration templates; maintain accurate change records per version control procedures.
• Deliver LIMS training, technical support, problem reporting, and resolution for QC, QA, AD, and Manufacturing teams.
• Evaluate LIMS data to provide ad hoc and long-term reporting solutions; identify process gaps and propose improvements.
• Write test scripts for new LIMS functionality and participate in validation of new functionality/releases.
• Develop and maintain process configurations based on end user procedures and requirements.
• Partner with the LIMS team, IT, and end users to ensure new functionality meets user requirements.
• Create and revise LIMS documentation: SOPs, Work Instructions, Design Specifications, and training materials.
• Support LIMS platform expansion by preparing and executing validation test scripts.
• Liaise with laboratory end users to ensure configuration changes meet user needs.
• Revise or develop Functional Requirement Specifications (FRS) and User Requirement Specifications (URS), plus other relevant documentation.
• Perform other related duties as assigned.

Benefits

• Competitive compensation with performance recognition
• Medical, dental, and vision coverage
• Retirement savings plan with company contribution
• Paid time off, company holidays, and paid parental leave
• Education assistance, professional development, and training
• Employee assistance program and wellness resources
• Inclusive culture with employee resource groups and opportunities to contribute to continuous improvement

What This Job Offers

• Job Type: Full-time
• Career Level: Senior