QC LIMS Lead – LabWare v8 for GMP Quality Control

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 100,000 - 150,000; Full time

Benefits offered by this job

Competitive compensation

Medical, dental, vision coverage

Retirement plan with company match

Paid time off and holidays

Education assistance and training

Employee assistance program

Inclusive culture and growth

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC seeks a Sr. Specialist 1, QC LIMS to configure, validate, and sustain a LabWare LIMS v8 environment supporting GMP QC testing and patient safety.

The role partners with QC, AD, Manufacturing, and IT to deliver compliant testing workflows, data integrity, and robust configurations. Candidates should have strong cGMP knowledge and cross-functional skills.

Qualifications

• Bachelor’s degree in CS/IT/Biology/Biochemistry or related discipline with 2+ years of experience; or Master’s degree with 0 years.
• Ability to function in a fast-paced, highly technical environment.
• Demonstrated ability to work cross-functionally and build partnerships across levels.
• Knowledge of cGMP/ICH/FDA regulations; familiarity with 21 CFR Part 11 and GAMP.
• Strong written and verbal communication, technical writing, and problem-solving skills.
• Understanding of pharma/biotech testing cycles or requirements.
• Ability to work effectively with diverse teams.

Responsibilities

• Participate in LabWare LIMS v8 site go-live including data migration, configuration, and validation.
• Collaborate with subject matter experts to document LabWare requirements.
• Configure LabWare objects: Specifications, Analyses, Batch Templates, Test Lists, QC Samples.
• Execute qualification/verification testing to support configurations.

Skills

cGMP/ICH/FDA knowledge

cross-functional collaboration

verbal and written communication

problem solving

pharmaceutical/biotech testing cycles

ability to work with diverse teams

Education

Bachelor's degree in CS/IT/Biology/Biochemistry or related field

Master's degree in same fields

Tools

LabWare LIMS

TrackWise (or similar quality system)

Job description

FUJIFILM Biotechnologies in Holly Springs, NC seeks a Sr. Specialist 1, QC LIMS to configure, validate, and sustain a LabWare LIMS v8 environment supporting GMP QC testing and patient safety.

The role partners with QC, AD, Manufacturing, and IT to deliver compliant testing workflows, data integrity, and robust configurations. Candidates should have strong cGMP knowledge and cross-functional skills.