QC Specialist II: Analytical Methods & Validation Lead

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

Benefits offered by this job

Health benefits

401(k) with company match

Paid time off

Job summary

Novartis in Morrisville, North Carolina, is seeking a QC Specialist II to support the growth of the Small Molecules QC laboratory. You will serve as a subject matter expert for complex analytical techniques and instrumentation, guiding testing, method transfer, validation, and data review within a GMP environment.

The role provides technical leadership in troubleshooting, equipment qualification, and lifecycle management while collaborating across QA, QC, MS&T, Engineering, and Validation to

Qualifications

• Hands-on experience with HPLC, GC, UPLC, and LC-MS including method validation and transfer.
• Experience with LabWare LIMS and Empower CDS preferred.
• Strong knowledge of GxP and ALCOA+ data integrity principles; familiarity with ICH Q2/Q10/Q14 and regulatory expectations.

Responsibilities

• Act as SME for complex analytical techniques and instrumentation (HPLC, UPLC, GC, LC-MS, ICP, dissolution, spectroscopy).
• Perform and troubleshoot chromatographic and wet-chemistry testing per GLP and cGMP requirements.
• Manage analytical method transfers, validation, troubleshooting, risk mitigation, and lifecycle management.
• Lead OOS and deviation investigations, including root-cause analysis and CAPA definition/tracking.
• Review and approve chromatographic data and analytical tests for release; ensure data integrity.

Skills

HPLC

GC

UPLC

LC-MS

Data integrity

Education

Bachelor's/Master's/PhD in Chemistry or related field

Tools

LabWare LIMS

Empower CDS

Job description

Novartis in Morrisville, North Carolina, is seeking a QC Specialist II to support the growth of the Small Molecules QC laboratory. You will serve as a subject matter expert for complex analytical techniques and instrumentation, guiding testing, method transfer, validation, and data review within a GMP environment.

The role provides technical leadership in troubleshooting, equipment qualification, and lifecycle management while collaborating across QA, QC, MS&T, Engineering, and Validation to