QC Specialist II: Lead Method Transfer & Validation

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

Job summary

Novartis Group Companies in Morrisville, NC seeks a QC Specialist II to support the start-up and growth of the Small Molecules QC lab. This role serves as a technical SME for complex analytical techniques and instrumentation while supporting analytical testing, investigations, method transfer, validation, and data review in a GMP environment.

The position collaborates across QA, QC, MS&T, Engineering, and Validation to ensure data integrity and regulatory compliance.

Qualifications

• Bachelor's, Master's, or PhD in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or related field, with cGMP-regulated experience.
• Hands-on experience with HPLC, GC, UPLC, LC-MS; LabWare LIMS and Empower CDS preferred.
• Proven experience in analytical method development, validation, transfer, troubleshooting, lifecycle management.
• Strong knowledge of complex analytical techniques and regulatory expectations (ICH, FDA/EMA).

Responsibilities

• Serve as SME for complex analytical techniques and instrumentation.
• Perform and troubleshoot chromatographic and wet-chemistry testing per GLP and cGMP.
• Manage analytical method transfers, validation, troubleshooting, and lifecycle management.
• Lead OOS and deviation investigations; conduct root-cause analysis and CAPA definition.
• Review and approve chromatographic and non-chromatographic data for analytical release.
• Develop and deliver site training for Empower CDS and analytical technologies.

Skills

Analytical Testing

Collaboration

Communication

Data Integrity

Decision Making

GMP

Managing Ambiguity

QA

Regulatory Compliance

QC

QMS

Regulatory Compliance

SOP

SPC

Validation Activities

Education

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

Tools

LabWare LIMS

Empower CDS

Job description

Novartis Group Companies in Morrisville, NC seeks a QC Specialist II to support the start-up and growth of the Small Molecules QC lab. This role serves as a technical SME for complex analytical techniques and instrumentation while supporting analytical testing, investigations, method transfer, validation, and data review in a GMP environment.

The position collaborates across QA, QC, MS&T, Engineering, and Validation to ensure data integrity and regulatory compliance.