QC Specialist II – LIMS/Master Data

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

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. 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 escalation 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.

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

Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives.

In the context of China Cross-Border Data Transfer (CBDT) policy, if you need to apply for a position in China, please go to the local Recruiting System TaleNov.

Salary Range $89,600.00 - $166,400.00