We are seeking a Specialist Quality Complaints to join the Product Complaints and Surveillance team as a Complaint Owner. The Product Complaints and Surveillance team owns and executes the end-to-end global complaint process and management system, ensuring appropriate business connectivity across Amgen. The team is focused on maintaining complaint processes and systems in a compliant state through adherence to quality standards and procedures while meeting current and emerging internal and external requirements. In addition, the team leverages information from the market to drive continuous improvement initiatives.

As a Specialist Quality Complaints, you will facilitate cross-functional teams in conducting both basic and complex complaint investigations, determining appropriate corrective and preventive actions, and assessing their effectiveness. You will also ensure the appropriate level of control for products in distribution and align complaint closure activities with established process metrics to support timely and compliant record closure.

Let's do this. Let's change the world.

In this vital role you will:

• Manage and investigate product quality complaints in compliance with applicable regulatory requirements and company procedures.
• Conduct complaint assessments, trend analyses, and documentation activities to ensure timely and accurate resolution.
• Facilitate cross-functional investigations and collaborate with Manufacturing, Supply Chain, Quality Assurance, Regulatory Affairs, and other key stakeholders to identify root causes and drive corrective and preventive actions (CAPAs).
• Ensure accurate, complete, and compliant documentation within quality management systems.
• Assess product impact and support decision-making related to product disposition and control in distribution.
• Monitor complaint performance metrics and ensure adherence to established timelines and closure requirements.
• Support Health Authority inspections and internal and external audits related to complaint management activities.
• Communicate investigation progress and outcomes to relevant stakeholders while maintaining high standards of quality and compliance.
• Analyze complaint data and trends to identify opportunities for continuous improvement and risk mitigation.
• Support the implementation and ongoing enhancement of global quality programs, processes, and best practices.