Deviations & Investigations Scientist
Core
Lead and document investigations for laboratory deviations, OOS, OOT, and quality events in a GMP-regulated environment.
Role type
Intermediate IC quality scientist (deviations & investigations)
Builds
Quality compliance documentation and CAPAs for laboratory operations
Domain
Life sciences / Pharmaceutical testing / GMP compliance
Deliverable
dashboards & analysis
Required skills
Root cause analysis, CAPA development, GMP/GLP knowledge, analytical data review, technical writing, LIMS usage
Preferred skills
HPLC, GC, stability testing, batch release support
Responsibilities
Lead and author laboratory investigations for deviations and quality events; Perform root cause analyses and support CAPA implementation; Review analytical data and documentation to support conclusions; Support stability testing and batch release activities; Collaborate with lab and quality teams to resolve compliance issues; Ensure investigations are completed accurately and within timelines; Maintain compliance with GMP, GLP, and regulatory requirements; Utilize LIMS to manage documentation; Prepare technical reports and investigation summaries; Identify quality trends for process improvements.
Seniority
Intermediate, hands-on IC