QC & LIMS Master Data Specialist II

Novartis

Morrisville (NC)

On-site

USD 90,000 - 166,000

Full time

9 days ago

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Job summary

Novartis in Morrisville, NC is seeking a QC Specialist II - LIMS/Master Data to build, maintain, and optimize LabWare LIMS supportingQuality Control operations. This role acts as SME for LIMS master data, workflows, audit trails, and Empower CDS, ensuring data integrity, laboratory efficiency, and regulatory compliance in a growing manufacturing environment.

The position requires a Bachelor’s degree in Chemistry, Biology, or a related field and hands-on LIMS master data experience; you will work

Qualifications

Responsibilities

Create, maintain, and update LabWare LIMS master data to support Quality Control operations.
Configure sample plans, products, product grades, project stages, analysis, components/specifications, COA setup, safety, suppliers, and lot testing control.
Execute requested change management actions in QMS and LIMS.
Support new product master data creation within LIMS. Support new template creation in LIMS.
Troubleshoot LIMS and Empower master data functional issues in collaboration with management, IT, and service provider.
Contribute to validation efforts for site LMS / Empower / NetLab and LabX workflows, enhancements and further site LIMS implementations.
Ensure all activities are in compliance with cGMP, including data integrity review and approval of analytical data and tests.
Report technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt.
Update and maintain SOPs as needed.