QA Deviation Specialist
Core
Identify, document, investigate, and resolve manufacturing, packaging, and laboratory deviations to ensure product quality and regulatory compliance.
Role type
Senior IC QA Deviation Specialist
Builds
Closed-loop investigations and continuous improvement initiatives for manufacturing and lab events
Domain
Life sciences / Pharmaceutical manufacturing
Required skills
Root cause analysis, deviation management, CAPA definition, SOP authoring, regulatory compliance, trend analysis, impact assessment, GMP/GDP adherence
Preferred skills
Chemistry background, cross-functional leadership, audit support
Technologies
Fishbone, 5 Why's
Responsibilities
Lead cross-functional investigations to determine root cause; Analyze deviation trends for continuous improvement; Author and approve investigation reports; Define CAPA criteria and evaluate effectiveness; Review and update SOPs; Support regulatory and customer audits
Seniority
Mid-level, hands-on IC