Enter a job title or keyword

Senior Specialist 1, Quality Control LIMS

Job Location:

Holly Springs, MS - USA

Monthly Salary: Not provided by the employer

Posted: 2 September 2026 (15 days ago)

Application Deadline: 30 November 2026

Vacancies: 1 Vacancy

Register to Apply

Department:

Quality Control

Job Summary

Position Overview

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 youll configure validate and sustain a critical system that enables compliant efficient testingdirectly 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 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof.

Were 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 were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!

Holly Springs North Carolina combines small-town warmth with proximity to Raleighs thriving tech scene making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70000 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: Description

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 LabWare 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)

Bachelors degree in Computer Science Information Technology Biology Microbiology Biochemistry or a related scientific discipline with 2 years of experience; or
Masters 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)

13 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.

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 We offer a competitive comprehensive benefits package designed to support your well-being and growth. Highlights typically include:

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

Equal Opportunity We are an equal opportunity employer. We welcome applicants of all backgrounds and are committed to a fair accessible and inclusive hiring process. If you require a reasonable accommodation at any stage please let us know.

EEO Information

Fujifilm is committedto providing equal opportunities in hiring promotion and advancement compensation benefits and training regardless of nationality age gender sexual orientation or gender identity race ethnicity religion political creed ideology national or social origin disability veteran status etc.

ADA Information

If you require reasonable accommodation in completing this application interviewing completing any pre-employment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department ().

Required Experience:

Senior IC

Apply Now

About Company

Fujifilm

View Profile View Profile

AI AutoApply

Apply to 100+ jobs with one click

AI AutoApply

AI Resume Builder

Create an ATS-ready CV in minutes

AI Resume Builder

AI Cover Letter

Write a personalized letter instantly

AI Cover Letter