Novartis
Quality Control Specialist II
$90K–$166K
Morrisville · Full-time · Posted Aug 28, 2026
- Experience
- Working experience is required; no number of years stated.
- Education
- Bachelor's, Master's, or PhD in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related scientific discipline.
About the job
Supports the start-up and growth of a GMP-regulated Quality Control laboratory through analytical testing, method lifecycle work, investigations, data review, and technical leadership.
What you'll do
- Perform and troubleshoot analytical testing of raw materials, in-process materials, finished products, and stability samples.
- Manage method transfers, validation, lifecycle activities, and OOS/deviation investigations, including root-cause analysis and CAPA.
- Review analytical data and support equipment qualification, laboratory training, and compliance with data-integrity and regulatory requirements.
What they ask for
- Bachelor's, Master's, or PhD in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related scientific discipline.
- 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 analytical method validation and transfer.
- Knowledge of analytical techniques, GxP, ALCOA+, ICH Q2, ICH Q10, ICH Q14, and relevant regulatory expectations.
Nice to have
- Experience with LabWare LIMS and Empower CDS.
- Prior experience developing and delivering technical training for analytical instrumentation, laboratory systems, or QC processes.
Pay
$89,600 - $166,400 per year (base salary)
Tools
HPLC, UPLC, GC, LC-MS, ICP spectroscopy, Empower CDS, LabWare LIMS
Model-written summary · the original posting is authoritative