Senior Specialist , Quality Control LIMS

Position: Senior Specialist 1, Quality Control LIMS
** Position Overview*
* Help build and optimize a best-in-class Lab Ware 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.

** 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:

** Job Description*
* About Us

We are a collaborative Quality Control LIMS team partnering closely with Quality Control, Analytical Development, Manufacturing, IT, and Quality Assurance. Our mission is to ensure our Lab Ware LIMS operates in a robust, validated, and compliant state aligned with cGMP, ICH, FDA, 21 CFR Part 11, and GAMP expectations. We value curiosity, accountability, and cross-functional partnership, and we foster an inclusive environment where every voice is heard and respected.

Minimum qualifications (must-have)

+ 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 (nice-to-have)

+ 1-3 years of experience in a cGMP Quality Control department or FDA-regulated industry (drugs/biologics)

+ Previous experience with Lab Ware LIMS development or other LIMS software development

+

Experience with 21 CFR Part 11 and GAMP (applied/working experience)

+ Track Wise (or similar quality system) experience for at least 1 year

+ Leadership aptitude

Responsibilities

+ Participate in the Lab Ware 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 Lab Ware requirements.

+ Configure basic and advanced Lab Ware 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 Lab Ware configurations.

+ Maintain and, when needed, repair configuration objects within Lab Ware 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…