LIMS Master Data QC Specialist II

U473 (FCRS = US473) Novartis Innovative Technologies Inc; Morrisville (NC); On-site; USD 90,000 - 166,000; Full time

Benefits offered by this job

Comprehensive benefits package

401(k) with company match

Generous paid time off

Job summary

Novartis is seeking a QC Specialist II - LIMS/Master Data in Morrisville, NC to build, maintain, and optimize LabWare LIMS supporting Quality Control operations. You will work as a domain expert on LIMS master data, workflows, and Empower CDS while contributing to validation and compliance activities.

The role requires a chemistry/biology background, hands-on LIMS experience, and strong collaboration with IT and QA teams in a cGMP environment.

Qualifications

• Bachelor's degree in Chemistry, Biology, or a related scientific discipline.
• LIMS master data experience is required, including foundational experience with LabWare LIMS.
• Understanding of structures and data flow requirements in LIMS systems.
• Empower Master Data and method building experience is required.
• Experience implementing instrument connections, Environmental Monitoring test plans, test scheduling and LES implementations.
• Knowledge of ICH Q10, data integrity, change control, and Good Documentation Practices.
• Strong communication skills with the ability to identify, prioritize, and escalation issues in a dynamic environment.

Responsibilities

• Create, maintain, and update LabWare LIMS master data to support Quality Control operations.
• Serve as subject matter expert for LIMS master data, workflows and audit trail and Empower CDS.
• 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 issues with IT and service providers.
• Contribute to validation efforts for site LMS / Empower / NetLab and LabX workflows and 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 within 24 hours.
• Update and maintain SOPs as needed.

Skills

Analytical Testing

Data Integrity

Quality Assurance

GMP

Regulatory Compliance

Decision Making

Communication

Collaboration

Managing Ambiguity

Quality Management Systems

SOP

Statistical Process Control

Education

Bachelor's degree in Chemistry, Biology, or a related scientific discipline

Tools

LabWare LIMS

Empower CDS

NetLab

LabX

Job description

Novartis is seeking a QC Specialist II - LIMS/Master Data in Morrisville, NC to build, maintain, and optimize LabWare LIMS supporting Quality Control operations. You will work as a domain expert on LIMS master data, workflows, and Empower CDS while contributing to validation and compliance activities.

The role requires a chemistry/biology background, hands-on LIMS experience, and strong collaboration with IT and QA teams in a cGMP environment.