Quality Control Specialist II
Core
Technical subject matter expert supporting the start-up and growth of a GMP-regulated Small Molecules Quality Control laboratory, performing complex analytical testing, method validation, and investigations.
Role type
Senior IC Quality Control Specialist (Analytical Chemistry)
Builds
Pharmaceutical raw materials, in-process materials, finished products, and stability samples
Domain
Pharmaceutical manufacturing / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
HPLC, UPLC, GC, LC-MS, ICP spectroscopy, dissolution testing, spectroscopy, physicochemical testing, analytical method validation, method transfer, OOS investigation, root-cause analysis, CAPA definition, equipment qualification (IQ/OQ/PQ), data review and approval, GxP compliance, ALCOA+ principles
Preferred skills
LabWare LIMS, Empower CDS, technical training delivery
Technologies
HPLC, UPLC, GC, LC-MS, ICP, Empower CDS, LabWare LIMS
Responsibilities
Perform and troubleshoot chromatographic and wet-chemistry testing; Manage analytical method transfers, validation, and lifecycle management; Lead OOS and deviation investigations; Review and approve analytical data; Provide expert support for laboratory equipment qualification and validation; Develop and deliver site training for analytical technologies and processes
Seniority
Mid-Senior, hands-on IC
