QC Laboratory IT Specialist (f/m/d)

QC Laboratory IT Specialist (f/m/d)

The QC IT Systems Specialist provides hands‑on operational support to the QC Lab Informatics team during site start‑up and early operations. The role focuses on setting up, configuring, and stabilizing the QC IT system landscape to enable a paperless QC laboratory strategy from day one.

This position is strongly execution‑oriented and acts as a technical delivery resource embedded within QC Lab Informatics. The specialist works closely with local and global QC IT teams to build, configure, and verify system content in alignment with global standards and site‑specific requirements.

The scope includes multiple QC IT platforms, primarily LabVantage, TULIP, NuGenesis, and MODA.

Key Responsibilities

• Timely execution of system setup, configuration, and master data activities
• GMP‑compliant execution in line with SOPs, ALCOA+ principles, and regulatory requirements
• Maintenance of accurate documentation according to GDP
• Support of inspection readiness
• Cross‑functional collaboration with QC, QA, and global IT teams
• Knowledge transfer to internal teams

Required Qualifications

• Proven experience in QC Lab Informatics / QC IT within a GMP environment
• Hands‑on experience with at least two systems: LabVantage, TULIP, NuGenesis, MODA
• Experience with site start‑ups, LIMS deployments, or paperless labs
• Knowledge of data integrity, CSV, instrument qualification, and GMP requirements
• Bachelor's degree in life sciences, pharmacy, computer science, engineering, or equivalent experience