LIMS QC Developer: GMP Data, Automation & Insights

FUJIFILM Holdings America Corporation; North Carolina; On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid time off

Job summary

FUJIFILM Biotechnologies in North Carolina is seeking a QC LIMS Developer to design, configure, validate, and support LIMS capabilities for Quality Control laboratories. You will build compliant digital workflows for sample lifecycle, CoAs, instrument integrations, and reporting to ensure data integrity and on-time product releases.

Role emphasizes GMP compliance, CSV documentation, and SDLC/Agile practices.

Qualifications

• Bachelor’s degree in CS/IS, Chemistry, Biochemistry, or related field; Master’s a plus.
• 3–7 years configuring and supporting LIMS in GMP environments (pharma/biotech/med device).
• Hands‑on with LabWare LIMS, LabVantage, SampleManager, Nautilus, STARLIMS.
• Experience with FDA 21 CFR 210/211/11, EU Annex 11, GAMP 5, ICH Q9/Q10.

Responsibilities

• Translate QC business requirements into LIMS workflows (sample login, testing, results entry/review/approval, CoA generation, stability, EM, utilities, raw materials, in-process/finished product).
• Configure master data: tests, methods, specifications, limits, calculations, units, instruments, users/roles, security, audit trails, electronic signatures.
• Build dashboards, queries, and reports (KPIs, turnaround time, RFT metrics, EM trending, stability pulls) using native LIMS tools.
• Integrate instruments and systems (CDS such as Empower; ELN; ERP like SAP/Oracle)
• Implement results parsing and automated calculations; manage instrument metadata and result mapping.
• Author and execute CSV deliverables: URS, FRS, HDS, configuration specs, risk assessments, test scripts (IQ/OQ/PQ)
• Ensure 21 CFR Part 11 / EU Annex 11 adherence, ALCOA+ data integrity, and Good Documentation Practices; maintain change control.
• Support audits/inspections; maintain audit-readiness for LIMS and connected systems.

Skills

SQL

LabWare LIMS

LabVantage

Java

Groovy

.NET

Python

XML/JSON

Education

Bachelor’s in Computer Science/Information Systems, Chemistry, Biochemistry, or related field

Master’s degree is a plus

Tools

Empower

Chromeleon

Crystal Reports

JasperReports

Power BI

Tableau

Job description

FUJIFILM Biotechnologies in North Carolina is seeking a QC LIMS Developer to design, configure, validate, and support LIMS capabilities for Quality Control laboratories. You will build compliant digital workflows for sample lifecycle, CoAs, instrument integrations, and reporting to ensure data integrity and on-time product releases.

Role emphasizes GMP compliance, CSV documentation, and SDLC/Agile practices.