QC Specialist II - Expert in HPLC/LC-MS Methodology

Novartis; Morristown (VT); On-site; USD 90,000 - 166,000; Full time

Benefits offered by this job

Health, life and disability benefits

401(k) with company match

Generous leave and holiday program

Job summary

Novartis is seeking a QC Specialist II in Morrisville, NC to support the Small Molecules Quality Control lab. You will serve as SME for advanced analytical techniques, support method transfer/validation, investigations, data review, and lifecycle management within a GMP framework.

You will lead OOS/deviation investigations, review data for regulatory readiness, and train staff on Empower CDS and QC processes, ensuring ALCOA+ data integrity and compliance with ICH/GxP standards.

Qualifications

• Bachelor’s, Master’s, or PhD in Chemistry or related science with cGMP experience.
• Hands-on with HPLC/UPLC/GC/LC-MS and method validation or transfer.
• Strong knowledge of GxP, ICH guidelines and FDA/EMA expectations.
• Experience with analytical method development, validation, transfer, and lifecycle management.

Responsibilities

• Serve as SME for complex analytical techniques and instrumentation (HPLC, UPLC, GC, LC-MS, ICP, dissolution, spectroscopy).
• Perform and troubleshoot chromatographic and wet-chemistry tests per GLP/g cGMP.
• Lead method transfers, validation, troubleshooting, risk mitigation, lifecycle management.
• Lead OOS and deviation investigations; perform root-cause analysis and CAPA.
• Review/approve analytical data for accuracy and regulatory readiness.
• Support equipment qualification and validation (IQ/OQ/PQ, calibration).
• Develop and deliver Empower CDS, instrumentation and QC training.
• Ensure compliance with GxP, ALCOA+ data integrity, and Novartis policies.

Skills

Analytical testing

Collaboration

Communication

Decision making

GxP knowledge

ALCOA+ data integrity

Regulatory compliance

Quality management systems

Education

Bachelor’s/Master’s/PhD in Chemistry or related

Tools

LabWare LIMS

Empower CDS

Job description

Novartis is seeking a QC Specialist II in Morrisville, NC to support the Small Molecules Quality Control lab. You will serve as SME for advanced analytical techniques, support method transfer/validation, investigations, data review, and lifecycle management within a GMP framework.

You will lead OOS/deviation investigations, review data for regulatory readiness, and train staff on Empower CDS and QC processes, ensuring ALCOA+ data integrity and compliance with ICH/GxP standards.