Senior QC LIMS Specialist - Go-Live & Validation

FUJIFILM Holdings America Corporation; Holly Springs (NC); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

Retirement plan with company match

Paid time off and holidays

Education assistance and training

Employee assistance program

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC is seeking a Sr. Specialist 1, QC LIMS to build and sustain a LabWare LIMS v8 environment in a GMP setting. You will configure, validate, and support QC workflows, ensuring compliant, efficient testing that impacts product quality and patient safety.

Collaborate with QC, Analytical Development, Manufacturing, IT, and QA to meet 21 CFR Part 11, GAMP, and regulatory expectations. Strong LabWare knowledge and cross-functional teamwork are essential.

Qualifications

• Bachelor’s degree in a scientific or IT field with 2+ years of experience; or Master’s degree with 0 years’ experience.
• Master’s degree in the same fields with 0 years of experience.
• 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

Responsibilities

• Participate in LabWare LIMS v8 site go-live, including data migration, configuration, validation, and cross-functional coordination.
• Define and document LabWare requirements with business SMEs.
• Configure LabWare LIMS objects: Specifications, Analyses, Batch Templates, Test Lists, QC Samples.
• Execute qualification/verification testing for new/updated LabWare configurations.
• Maintain and repair LabWare configuration objects and create change records.

Skills

Cross-functional teamwork

cGMP/ICH/FDA knowledge

Communication (verbal & written)

Problem solving

Pharma/biotech testing knowledge

Education

Bachelor’s degree in Computer Science, IT, Biology, Microbiology, Biochemistry, or related field

Master’s degree in relevant field

Tools

LabWare LIMS

TrackWise

Job description

FUJIFILM Biotechnologies in Holly Springs, NC is seeking a Sr. Specialist 1, QC LIMS to build and sustain a LabWare LIMS v8 environment in a GMP setting. You will configure, validate, and support QC workflows, ensuring compliant, efficient testing that impacts product quality and patient safety.

Collaborate with QC, Analytical Development, Manufacturing, IT, and QA to meet 21 CFR Part 11, GAMP, and regulatory expectations. Strong LabWare knowledge and cross-functional teamwork are essential.