Quality Control Specialist II

Novartis • Morrisville, VT

10d • $89,600 - $166,400 • Onsite

About The Position

The QC Specialist II is a highly skilled laboratory professional who will support the start-up and growth of Novartis' Small Molecules Quality Control laboratory in Morrisville, North Carolina. This role serves as a technical subject matter expert for complex analytical techniques and instrumentation while supporting analytical testing, investigations, method transfer, validation, and data review activities within a GMP-regulated environment.

Working within a growing site organization, the QC Specialist II will support the transfer, qualification, validation, and lifecycle management of analytical methods used to test pharmaceutical raw materials, in-process materials, finished products, and stability samples. The role will also provide technical leadership in troubleshooting, analytical investigations, equipment qualification, and training activities while partnering across Quality, Manufacturing, MS&T, Engineering, and Validation teams.

This is an exciting opportunity to build the technical capabilities, laboratory systems, and quality infrastructure required to support the continued growth of the Morrisville manufacturing site.

Requirements

• 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.
• Hands-on experience with 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.

Nice To Haves

• Prior experience developing and delivering technical training related to analytical instrumentation, laboratory systems, or quality control processes.

Responsibilities

• 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.

Benefits

• health
• life
• disability benefits
• 401(k) with company contribution and match
• generous time off package including vacation, personal days, holidays and other leaves

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level