Scientist II, Investigations
Core
Lead and support laboratory investigations in a regulated cGMP environment to identify root causes and drive corrective and preventive actions.
Role type
Scientist II (Investigations)
Builds
Quality and laboratory investigation reports, root cause analyses, and CAPA documentation
Domain
Life Sciences / Biochemistry / Pharmaceutical Testing
Deliverable
dashboards & analysis
Required skills
Root cause analysis (Fishbone, 5 Whys), cGMP/GLP compliance, analytical testing (HPLC, CE-SDS, icIEF, ELISA, cell-based assays), CAPA management, cross-functional collaboration, data review
Preferred skills
LIMS system experience, internal investigational process knowledge
Technologies
HPLC, CE-SDS, icIEF, ELISA, cell-based assays, LIMS
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; Collaborate with Quality, Operations, Analytical Development, and other departments to resolve issues within established timelines; 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.
Seniority
Mid-level IC