QC Specialist II – LIMS/Master Data

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.

• 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.

• 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.

To learn more about the culture, rewards and benefits we offer our people click here.