Senior QC LIMS Specialist – LabWare v8 Go-Live & Validation

Merck & Co.; Holly Springs (NC); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Retirement savings plan with company 2

Paid time off and holidays

Education assistance

Job summary

FUJIFILM Biotechnologies is seeking a Sr. Specialist 1, QC LIMS to configure, validate, and sustain a LabWare LIMS v8 environment supporting GMP QC activities. You will work with Quality Control, Analytical Development, Manufacturing, IT, and QA to ensure a robust, validated system.

The role requires a strong background in LabWare LIMS, cGMP regulations, and cross-functional collaboration to deliver compliant testing and data insights.”

Qualifications

• Bachelor's in a scientific or IT field with 2+ years of relevant experience; or Master’s with 0 years.
• Thorough knowledge of cGMP/ICH/FDA regulations; familiarity with 21 CFR Part 11 and GAMP.

Responsibilities

• Participate in LabWare LIMS v8 site go-live, including data migration and validation.
• Collaborate with SMEs to define LabWare requirements and configurations.
• Configure LabWare objects: Specifications, Analyses, Batch Templates, Test Lists, QC Samples.
• Execute qualification testing and support implementation of new configurations.
• Create and revise LIMS documentation, SOPs, and FRS/URS as needed.

Skills

LabWare LIMS

cGMP/ICH/FDA

Cross-functional collaboration

Validation testing

Technical writing

LIMS data analysis

Education

Bachelor’s degree in CS/IT/Biology/Biochemistry/M Biology or related

Master’s degree in same fields with 0 years" experience

Tools

LabWare LIMS

TrackWise

21 CFR Part 11 familiarity

Job description

FUJIFILM Biotechnologies is seeking a Sr. Specialist 1, QC LIMS to configure, validate, and sustain a LabWare LIMS v8 environment supporting GMP QC activities. You will work with Quality Control, Analytical Development, Manufacturing, IT, and QA to ensure a robust, validated system.

The role requires a strong background in LabWare LIMS, cGMP regulations, and cross-functional collaboration to deliver compliant testing and data insights.”