QC Specialist II: Lead Analytical Method Validation

U473 (FCRS = US473) Novartis Innovative Technologies Inc; Morrisville (NC); On-site; USD 90,000 - 166,000; Full time

Job summary

Novartis Innovative Technologies Inc in Morrisville, NC seeks a QC Specialist II to support a growing Small Molecules Quality Control lab. You will act as SME for analytical methods, lead transfers and validations, and collaborate across QA/QC, MS&T, Engineering, and Validation.

The role requires hands-on experience with HPLC/UPLC/GC/LC-MS, data review, and ensuring GxP compliance. Strong training and leadership skills are a plus in a GMP environment.

Qualifications

• Bachelor's, Master's, or PhD in Chemistry or related field with cGMP experience.
• Hands-on with HPLC/GC/UPLC/LC-MS and method validation/transfer.
• Experience with LabWare LIMS and Empower CDS preferred.

Responsibilities

• Serve as SME for complex analytical techniques and instrumentation.
• Perform and troubleshoot testing of materials and products per GLP/cGMP.
• Lead method transfers, validation, troubleshooting, and lifecycle management.
• Investigate OOS and deviations with root-cause analysis and CAPA.
• Review data and tests for readiness of analytical release.
• Support equipment qualification and calibration; provide training.

Skills

HPLC

UPLC

GC

LC-MS

ICP spectroscopy

Dissolution

Spectroscopy

Physicochemical testing

GxP

ALCOA+ data integrity

Education

Bachelor's, Master's, or PhD in Chemistry/Analytical Chemistry/Pharmaceutical Sciences

Tools

LabWare LIMS

Empower CDS

Job description

Novartis Innovative Technologies Inc in Morrisville, NC seeks a QC Specialist II to support a growing Small Molecules Quality Control lab. You will act as SME for analytical methods, lead transfers and validations, and collaborate across QA/QC, MS&T, Engineering, and Validation.

The role requires hands-on experience with HPLC/UPLC/GC/LC-MS, data review, and ensuring GxP compliance. Strong training and leadership skills are a plus in a GMP environment.