Quality Control Specialist II

Role: Support the startup and growth of Novartis' Small Molecules Quality Control laboratory in Morrisville, NC, serving as a technical subject matter expert in complex analytical techniques. Responsibilities: perform, troubleshoot, and review chromatography and physicochemical testing of raw materials, in-process, finished products, and stability samples within a GMP environment; lead analytical method transfer, validation, and lifecycle management; support investigations of OOS and deviations; oversee equipment qualification and validation; develop and deliver training on analytical systems and processes; ensure compliance with GxP, ALCOA+, and regulatory standards while collaborating across QA, QC, Manufacturing, MS&T, and Engineering. Requirements: Bachelor's, Master's, or PhD in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or related field; extensive hands-on experience with HPLC, UPLC, GC, LC-MS; proven expertise in analytical method development, validation, troubleshooting, and lifecycle management; strong knowledge of GxP, data integrity principles, and relevant regulatory expectations. Preferred: experience with LabWare LIMS, Empower CDS, and technical training development. High-Value: GMP-regulated analytical testing, complex instrumentation expertise, cross-functional collaboration, site startup, and growth support.