Senior Specialist 1, Quality Control LIMS

About the role

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.

About Us

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.

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.

Minimum Qualifications

• 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

Preferred Qualifications

• 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

Work environment and physical requirements

• Ability to sit for prolonged periods (approximately 240 minutes daily); perform repetitive motions with wrists/hands/fingers.
• Ability to lift/move objects up to 10 lbs.
• Ability to discern audible cues and perform tasks requiring 20/20 corrected vision, including color differentiation.
• No routine requirement for respiratory protection, working at heights, operating motor vehicles/PITs, or working in extreme temperatures.

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