AS&T Specialist
Core
Support the start-up and growth of a pharmaceutical Quality Control laboratory by executing analytical method validation, transfer, and lifecycle management, and managing laboratory equipment qualification and testing.
Role type
Senior IC analytical specialist (pharmaceutical QC)
Builds
Pharmaceutical raw materials, intermediates, and finished products testing capabilities
Domain
Pharmaceutical manufacturing / Quality Control
Required skills
Analytical method validation, HPLC/UPLC/GC/LC-MS/ICP spectroscopy, equipment qualification, cGxP compliance, data integrity, root cause analysis, CAPA development, LabWare LIMS, Empower CDS
Preferred skills
Method optimization, computerized system validation (CSV), product transfers, continuous improvement
Technologies
HPLC, UPLC, GC, LC-MS, ICP spectroscopy, dissolution testers, LabWare LIMS, Empower CDS
Responsibilities
Execute analytical method validation, transfer, and lifecycle management; Provide scientific support for OOS investigations and troubleshooting; Coordinate equipment qualification, calibration, and maintenance; Lead equipment qualification and CSV support; Perform complex analytical testing; Author and maintain GxP-compliant documentation
Seniority
Senior, hands-on IC
