Principal Scientist II, Investigations
Core
Lead and support laboratory investigations in a regulated cGMP environment to identify root causes and drive corrective actions.
Role type
Senior IC quality scientist (investigations)
Builds
Quality resolutions and compliant documentation for pharmaceutical clients
Domain
Life sciences / Pharmaceutical testing
Deliverable
dashboards & analysis
Required skills
Root cause analysis, CAPA management, cGMP/GLP compliance, analytical data review, multi-project management
Preferred skills
LIMS system experience, knowledge of internal investigational processes
Technologies
HPLC, CE-SDS, icIEF, ELISA, cell-based assays
Responsibilities
Conduct and support laboratory investigations in compliance with cGMP and GLP requirements; Perform root cause analyses using tools such as Fishbone Diagrams and 5 Whys; Lead and document deviations, investigations, and CAPAs through completion; Review data and documentation to ensure accuracy, quality, and regulatory compliance; Assess analytical results generated using techniques such as HPLC, CE-SDS, icIEF, ELISA, and cell-based assays; Manage multiple investigations and projects simultaneously while meeting deadlines
Seniority
Senior, hands-on IC