QC LIMS Developer — GMP‑Backed Data Integrity & Integrations

Merck & Co.; North Carolina; On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) savings plan

Paid vacation and holidays

Employee assistance programs

Job summary

FUJIFILM Biotechnologies seeks a QC LIMS Developer to design, configure, validate, and support LIMS for Quality Control labs. You will build compliant digital workflows for sample lifecycles, CoAs, instrument integrations, and reporting, ensuring data integrity and GMP compliance.

Join a cross-functional team in the RTP/Morrisville area, focusing on continuous improvement, SDLC governance, and user enablement across QC, QA, and manufacturing to support right‑first‑time releases.

Qualifications

• 3–7 years configuring and supporting LIMS in GMP environments.
• Hands-on with LabWare or LabVantage platforms.
• Familiar with FDA 21 CFR 210/211/11, EU Annex 11, GAMP 5.
• Understanding QC lab processes and workflows.

Responsibilities

• Design and configure LIMS workflows for QC sample lifecycle.
• Integrate instruments and systems (Empower; SAP/Oracle).
• Validate and author CSV deliverables and validation docs.
• Provide application support, incident management, and SDLC governance.
• Create user guides and train end users across departments.
• Lead data migration and master data updates.

Skills

SQL

Documentation

Communication

Analytical thinking

Education

Bachelor's degree in CS/IS/chemistry/biochemistry

Tools

LabWare LIMS

LabVantage

Empower

Chromeleon

ELN/LES integrations

Oracle

SQL Server

Power BI

Crystal Reports

Job description

FUJIFILM Biotechnologies seeks a QC LIMS Developer to design, configure, validate, and support LIMS for Quality Control labs. You will build compliant digital workflows for sample lifecycles, CoAs, instrument integrations, and reporting, ensuring data integrity and GMP compliance.

Join a cross-functional team in the RTP/Morrisville area, focusing on continuous improvement, SDLC governance, and user enablement across QC, QA, and manufacturing to support right‑first‑time releases.