Specialist - Manufacturing Investigations

About the Role Join Amgen's North Carolina Biologics Drug Substance Manufacturing plant as a Specialist in Manufacturing Investigations. You will be a key member responsible for investigating major deviations, leading root cause analysis, developing CAPAs, and coordinating cross-functional teams, while communicating with stakeholders across Process Development, Facilities & Engineering, Automation, EHSS, and Quality. This role focuses on ensuring investigations are conducted thoroughly, documented compliantly, and improvements are driven in the investigation process. What You'll Do

• Manage Major deviation investigations, including assembling investigation teams, leading root cause analysis, development of CAPAs, and compliant documentation of all findings.
• Drive improvements to the investigation process.
• Present investigations to regulatory inspectors, internal auditors, and management.
• Clearly communicate investigation progress to impacted areas and leadership.
• Coordinate and effectively lead cross-functional teams through complex investigations, and complete milestones on-schedule.
• Present complex topics to large and small groups at various levels and quickly understand and clearly communicate complex issues.
• Build effective relationships across functions.
• Navigate through ambiguity and provide a structured problem-solving approach.
• Apply inductive and deductive reasoning in the investigation process.
• Clear and concise technical writing.
• Use Operational Learning Team strategies to promote open collaboration with staff to maximize investigations. What We're Looking For
• Experience interfacing with GMP manufacturing teams and stakeholder groups including Process Development, Facilities & Engineering, Automation, EHSS, and Quality.
• Proven ability to manage major deviation investigations, root cause analysis, CAPA development, and compliant documentation.
• Strong communication skills to present to regulatory inspectors, internal auditors, and leadership; ability to communicate progress clearly to impacted areas.
• Demonstrated ability to lead cross-functional teams through complex investigations and meet milestones; ability to present complex topics to varied audiences.
• Relationship-building across functions; comfort navigating ambiguity; structured problem-solving approach.
• Proficient in inductive and deductive reasoning and technical writing.
• Familiarity with Operational Learning Team strategies to promote open collaboration.