QC Specialist II - LIMS/Master Data

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

Job summary

Novartis Group of Companies in Morrisville, North Carolina, seeks a QC Specialist II – LIMS/Master Data to build, maintain and optimize LabWare LIMS supporting Quality Control operations. You will act as SME for LIMS master data, workflows and audit trails, ensuring data integrity and compliance across a growing manufacturing environment.

The role emphasizes configuring master data, validating changes, and collaborating with IT to resolve issues while aligning with cGMP standards and the

Qualifications

• LIMS master data experience required.
• Foundational LabWare LIMS knowledge.
• Empower Master Data understanding.
• Familiarity with data integrity and cGMP.

Responsibilities

• Create, maintain and update LabWare LIMS master data for QC operations.
• Configure sample plans, products, grades, COA setup, safety, suppliers, and lot testing control.
• Support change management actions in QMS and LIMS.
• Assist with new product master data creation and template creation in LIMS.
• Troubleshoot LIMS and Empower master data issues with IT and service providers.
• Contribute to validation efforts for LMS/Empower/NetLab/LabX workflows, site LIMS implementations.
• Ensure activities comply with cGMP and perform data integrity review of analyses.

Job description

Job Description Summary

Location: Morrisville, North Carolina

Relocation Support: This role is based in Morrisville, North Carolina. Novartis is unable to offer relocation support: please only apply if accessible.

Job Description

At Novartis, quality data drives the delivery of medicines that patients depend on every day. As a QC Specialist II - LIMS/Master Data, you will play a critical role in building, maintaining, and optimizing LabWare LIMS that supports Quality Control operations. This is an exciting opportunity to combine your scientific background, technical expertise, and problem-solving skills to influence data integrity, laboratory efficiency, and compliance across a growing manufacturing environment while helping ensure the highest standards of product quality.

Key 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, certificate of analysis (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, Information Technology, and service provider as necessary.
• 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.

Essential Requirements

• 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 International Council for Harmonisation Q10 principles, data integrity requirements, change control, and Good Documentation Practices.
• Strong communication skills with the ability to identify, prioritize, and elevate issues in a dynamic environment.

Desirable Requirements

• At least 1 year of GMP laboratory and system infrastructure experience
• Applied working knowledge of various laboratory instrumentation.

The salary for this position is expected to range between $89,600 and $166,400 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [e-mail] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$89,600.00 - $166,400.00

Skills Desired

Analytical Testing, Collaboration, Communication, Data Integrity, Decision Making, Good Manufacturing Practices (GMP), Managing Ambiguity, Quality Assurance (QA), Quality Compliance, Quality Control (QC), Quality Management Systems (QMS), Regulatory Compliance, Standard Operating Procedure (SOP), Statistical Process Control (SPC), Validation Activities