Senior Specialist – Complex Investigations

Role: Senior Specialist in Complex Investigations at Amgen's biologics manufacturing site, leading high-risk investigations to ensure quality, compliance, and patient safety. Responsibilities: direct cross-functional investigation teams, utilize advanced root cause analysis methods, develop effective CAPAs, and communicate findings to leadership; support regulatory inspections and internal audits; identify systemic issues and drive process improvements; mentor investigators and enhance investigation practices. Requirements: Doctorate with 2+ years, Master's with 4+ years, or Bachelor's with 6+ years in biotechnology or pharmaceuticals, with extensive experience leading investigations in GMP-regulated environments. High-value: biologics, drug substance manufacturing, complex deviation analysis, GMP, regulatory compliance, investigation management tools like Veeva QMS, and cross-functional stakeholder engagement. Work setup: not specified, but likely on-site with possible flexibility.