QC Data Integrity Specialist II — LIMS/LabWare

Novartis; Morrisville (NC); On-site; USD 90,000 - 166,000; Full time

Benefits offered by this job

Health benefits

401(k) with company match

Equity awards eligibility

Paid time off

Job summary

Novartis in Morrisville, NC, seeks a QC Specialist II to lead LabWare LIMS master data and quality data integrity for QC operations. You will manage master data, configure COAs, and support QMS/LIMS changes in a regulated manufacturing environment.

The role requires LabWare LIMS experience and expertise in data integrity, cGMP, and collaboration with IT and service providers to validate workflows across LMS/Empower/NetLab/LabX. A Bachelor’s degree in a scientific field is required.

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.

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 and new template creation in LIMS.
• Troubleshoot LIMS and Empower master data functional issues with IT and service provider.
• Contribute to validation efforts for site LMS / Empower / NetLab and LabX workflows.
• 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 cases related to Novartis products within 24 hours.
• Update and maintain SOPs as needed.

Skills

LIMS master data

LabWare LIMS

Data integrity

QMS/LIMS change management

Analytical data review

Audit trail & Empower CDS

Instrument connections knowledge

Communication skills

Education

Bachelor’s degree in Chemistry or Biology

Tools

LabWare LIMS

Empower

NetLab

LabX

Job description

Novartis in Morrisville, NC, seeks a QC Specialist II to lead LabWare LIMS master data and quality data integrity for QC operations. You will manage master data, configure COAs, and support QMS/LIMS changes in a regulated manufacturing environment.

The role requires LabWare LIMS experience and expertise in data integrity, cGMP, and collaboration with IT and service providers to validate workflows across LMS/Empower/NetLab/LabX. A Bachelor’s degree in a scientific field is required.