Specialist, Manufacturing

Job description

Career Category Manufacturing Job Description: Specialist Manufacturing Overview: Reporting to the Sr Manager Deviations Manufacturing Support, this position will manage the manufacturing deviations for Amgen Dun Laoghaire (ADL). The Manufacturing Specialist (Investigation Lead) will be primarily responsible for leading investigations for fill/finish/inspection and packaging deviations. Specialists will also be involved in applying process, quality, compliance, and analytical knowledge to complete the following: Qualifications: - Manage deviation investigations, including establishing investigation teams, leading root cause analysis, development of CAPAs, completing product impact assessments and writing compliant documentation of all findings. - Clear and concise technical writing of complex investigations - Drive improvements to the investigation process - Present investigations to regulatory inspectors and internal auditors - Clearly communicate investigation progress to impacted areas and leadership - Coordinate and lead cross-functional teams through complex investigations, and complete tasks on-schedule. - Project management of the investigations end to end - Present complex...