Senior Associate Quality Complaints

About the role

Amgen is looking for a Senior Associate Quality Complaints to own and implement its end-to-end global complaint process and management system. The role keeps complaint processes compliant with quality operating standards and procedures, and turns market information into continuous improvement.

Key responsibilities

• Conduct low to medium complexity complaint investigations and decide whether they need further investigation
• Evaluate and ensure triaged product complaint records align with applicable procedures, and own complaint records with basic investigations
• Ensure the quality of complaint records and complete assigned assessments per procedure
• Apply analytical skills to evaluate complex situations using multiple sources of information
• Implement the complaint process per SOP requirements and own or manage the review/approval flow in CDOCS of controlled documents
• Manage assigned projects or tasks to agreed results, with proactive communication, status updates and tracker maintenance

Required profile

• Basic qualification: Master's degree and 1 to 3 years of quality experience, or Bachelor's degree and 3 to 5 years, or Diploma and 7 to 9 years of quality experience
• Preferred: biotech, medical device or pharmaceutical quality or manufacturing experience
• Preferred: Bachelor's degree in a science field
• Preferred: ability to manage workload to timelines, familiarity with basic project management tools, and experience in a matrixed environment with site, functional and senior management leadership

Required skills

• Understanding of quality and industry requirements of a QMS
• Understanding of manufacturing/testing processes (API, drug substance, drug product, packaging, device)
• Preferred: ability to drive decisions using DAI principles and to negotiate positions after feedback
• Preferred: demonstrated ability to lead functional teams and deliver timely, high-quality results

What we offer

• Base salary plus competitive Total Rewards plans aligned with local industry standards
• Support for professional and personal growth and well-being