Quality Control Specialist II
Novartis
August 29, 2026
On-site
Morrisville, NC
Operations
Key Responsibilities:
- Serve as a subject matter expert for complex analytical techniques and instrumentation (HPLC, UPLC, GC, LC-MS, ICP spectroscopy, dissolution, spectroscopy, physicochemical testing).
- Perform and troubleshoot chromatographic and wet-chemistry testing of raw materials, in-process materials, finished products, and stability samples in compliance with GLP and cGMP.
- Manage analytical method transfers, validation, troubleshooting, risk mitigation, and lifecycle management.
- Lead and support OOS and deviation investigations (root-cause analysis, CAPA definition, issue resolution, KPI/KQI trending).
- Review and approve analytical data to ensure data integrity, accuracy, and readiness for analytical release.
- Support laboratory equipment and system qualification/validation (URS, FRS, IQ/OQ/PQ, calibration, maintenance, qualification-plan preparation).
- Develop and deliver training for Empower CDS, analytical technologies, lab processes, and applicable quality requirements.
- Ensure GxP and ALCOA+ data-integrity compliance while partnering cross-functionally.
Essential Requirements:
- BS/MS/PhD in Chemistry/Analytical Chemistry/Pharmaceutical Sciences (or related), with experience in technical drug development/manufacturing/analytics/quality in a cGMP environment.
- Hands-on experience with HPLC, GC, UPLC, and/or LC-MS; analytical method validation/transfer experience; LabWare LIMS and Empower CDS preferred.
- Proven experience in analytical method development, validation, transfer, troubleshooting, and lifecycle management.
- Strong technical knowledge of complex analytical techniques (HPLC/UPLC/GC/ICP/dissolution/LC-MS/spectroscopy/physicochemical testing).
- Knowledge of GxP, ALCOA+; ICH Q2/Q10/Q14; FDA/EMA/regulatory expectations; and cGMP operations.
Desirable Requirement:
- Experience developing and delivering technical training related to analytical instrumentation, lab systems, or QC processes.
Compensation/Benefits (as stated):
- Salary range: $89,600–$166,400/year; performance-based cash incentive; possible annual equity awards; comprehensive benefits and time off package.
- Serve as a subject matter expert for complex analytical techniques and instrumentation (HPLC, UPLC, GC, LC-MS, ICP spectroscopy, dissolution, spectroscopy, physicochemical testing).
- Perform and troubleshoot chromatographic and wet-chemistry testing of raw materials, in-process materials, finished products, and stability samples in compliance with GLP and cGMP.
- Manage analytical method transfers, validation, troubleshooting, risk mitigation, and lifecycle management.
- Lead and support OOS and deviation investigations (root-cause analysis, CAPA definition, issue resolution, KPI/KQI trending).
- Review and approve analytical data to ensure data integrity, accuracy, and readiness for analytical release.
- Support laboratory equipment and system qualification/validation (URS, FRS, IQ/OQ/PQ, calibration, maintenance, qualification-plan preparation).
- Develop and deliver training for Empower CDS, analytical technologies, lab processes, and applicable quality requirements.
- Ensure GxP and ALCOA+ data-integrity compliance while partnering cross-functionally.
Essential Requirements:
- BS/MS/PhD in Chemistry/Analytical Chemistry/Pharmaceutical Sciences (or related), with experience in technical drug development/manufacturing/analytics/quality in a cGMP environment.
- Hands-on experience with HPLC, GC, UPLC, and/or LC-MS; analytical method validation/transfer experience; LabWare LIMS and Empower CDS preferred.
- Proven experience in analytical method development, validation, transfer, troubleshooting, and lifecycle management.
- Strong technical knowledge of complex analytical techniques (HPLC/UPLC/GC/ICP/dissolution/LC-MS/spectroscopy/physicochemical testing).
- Knowledge of GxP, ALCOA+; ICH Q2/Q10/Q14; FDA/EMA/regulatory expectations; and cGMP operations.
Desirable Requirement:
- Experience developing and delivering technical training related to analytical instrumentation, lab systems, or QC processes.
Compensation/Benefits (as stated):
- Salary range: $89,600–$166,400/year; performance-based cash incentive; possible annual equity awards; comprehensive benefits and time off package.