QC Specialist II – LIMS/Master Data
Location: Morrisville, North Carolina. Relocation support is not offered; applicants must be locally accessible.
About The Role
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.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? Learn more about our people and culture.
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 escalate 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.
Pay
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 such as relevant skills and experience and will be reviewed periodically after joining Novartis. Novartis may adjust the published salary range based on company and market factors. Compensation includes a performance‑based cash incentive and, depending on the role level, eligibility to be considered for annual equity awards.
Benefits
- Comprehensive benefits package for US‑based eligible employees: health, life and disability benefits.
- 401(k) with company contribution and match.
- Variety of other benefits.
- Generous time off package including vacation, personal days, holidays and other leaves.
- Performance‑based cash incentive.
- Eligibility for annual equity awards (role‑dependent).
- Access to the Novartis Benefits and Rewards handbook (PDF, 30 MB): Read our handbook.