Hiring: Quality Control Specialist II Company: Novartis Location: Morrisville, NC Job Posted Time: 2026-09-03 10:21:07 About the job Required Skills: •Serve as a subject matter expert for complex analytical techniques and instrumentation, including HPLC, UPLC, GC, LC-MS, ICP spectroscopy, dissolution, spectroscopy, and 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 requirements. •Manage analytical method transfers, validation, troubleshooting, risk mitigation, and lifecycle-management activities to support the Morrisville Quality Control laboratory. •Lead and support OOS and deviation investigations, including root-cause analysis, CAPA definition, issue resolution, and KPI/KQI trending. •Review and approve chromatographic and non-chromatographic data and analytical tests, ensuring data integrity, accuracy, and readiness for analytical release. •Provide expert support for laboratory equipment and system qualification and validation, including user requirements specifications, functional specifications, IQ/OQ/PQ activities, calibration, maintenance, and qualification-plan preparation. •Develop and deliver site training for Empower CDS, complex analytical technologies, laboratory processes, and applicable quality requirements. •Ensure activities comply with GxP, ALCOA+ data-integrity principles, regulatory requirements, and Novartis policies while collaborating across QA, QC, MS&T, Engineering, Operations, and other site functions. Qualifications: •Bachelor's, Master's, or PhD in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related scientific discipline, with working experience in technical drug development, manufacturing, analytics, or quality within a cGMP-regulated environment. •Applied hands-on capability in HPLC, GC, UPLC, and/or LC-MS analysis, including experience with analytical method validation and transfer; experience with LabWare LIMS and Empower CDS is preferred. •Proven experience in analytical method development, validation, transfer, troubleshooting, and lifecycle management. •Strong technical knowledge of complex analytical techniques, such as HPLC, UPLC, GC, ICP, dissolution, LC-MS, spectroscopy, and physicochemical testing. •Good understanding of GxP, ALCOA+ data-integrity principles, ICH Q2, ICH Q10, ICH Q14, and relevant FDA, EMA, and other regulatory expectations. •Broad knowledge of cGMP requirements and experience working within technical drug development, manufacturing, analytical, or quality operations. •Prior experience developing and delivering technical training related to analytical instrumentation, laboratory systems, or quality control processes. •To learn more about the culture, rewards and benefits we offer our people click here. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!