Quality Control Specialist II

Band

Level 3

Job Description Summary

#LI-Onsite

Location: Morrisville North Carolina

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 help build the technical capabilities laboratory systems and quality infrastructure required to support the continued growth of the Morrisville manufacturing site.

Job Description

• 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.

• Bachelors Masters 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.

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

The salary for this position is expected to range between $89600 - $166400 per year. The final salary offered is determined based on factors like but not limited to relevant skills and experience and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and depending on the level of the role eligibility to be considered for annual equity -based eligible employees will receive a comprehensive benefits package that includes health life and disability benefits a 401(k) with company contribution and match and a variety of other addition employees are eligible for a generous time off package including vacation personal days holidays and other leaves.

To learn more about the culture rewards and benefits we offer our people click here.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion gender national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please send an e-mail to call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Range

$89600.00 - $166400.00

Skills Desired

Analytical Testing Collaboration Communication Data Integrity Decision Making Good Manufacturing Practices (GMP) Managing Ambiguity Quality Assurance (QA) Quality Compliance Quality Control (QC) Quality Management Systems (QMS) Regulatory Compliance Standard Operating Procedure (SOP) Statistical Process Control (SPC) Validation Activities