Associate Quality Complaints
By Admin · Quality Assurance & Quality Control

ROLE OVERVIEW
Own and execute quality complaint activities across the global complaint process, ensuring compliant handling, accurate records, timely closure, and appropriate escalation. The role connects customer feedback with quality processes and continuous improvement.
ROLE DEFINITION & RESPONSIBILITIES
- •Evaluate and ensure triaged product complaint records remain aligned with applicable procedures
- •Evaluate and manage customer feedback records through closure
- •Evaluate records determined to be voided and complete the void process
- •Own and manage complaint records with limited information
- •Complete assigned assessments according to applicable procedures
- •Ensure accuracy and quality of complaint records and drive complaint processes according to SOP requirements
- •Own or handle controlled-document review and approval workflows in CDOCS while maintaining required format, content, usability, accuracy, consistency, and quality
- •Support assigned projects through timely communication, status updates, tracker maintenance, and tool management
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Bachelor's degree with 3-5 years of experience in Pharma, Life Sciences, or Biotechnology
- OR Master's degree with 2-4 years of experience in Pharma, Life Sciences, or Biotechnology
- Ability to understand and follow processes and process instructions
- Strong attention to detail and written/verbal communication skills
PREFERRED QUALIFICATIONS
- •Quality or manufacturing experience in biotechnology, medical device, or pharmaceutical industry
- •Understanding of QMS requirements and applicable manufacturing/testing processes
- •Experience with controlled-document or learning management systems
- •Practical experience with Microsoft Word and Excel
- •Experience working in matrixed or cross-functional teams
REQUIRED VERIFIED SKILLS
COMPENSATION & REWARDS
ORGANIZATION CONTEXT & CULTURE
Amgen is a global biotechnology company founded in 1980 that develops, manufactures, and delivers innovative medicines intended to help patients living with serious illnesses. Its stated focus includes Oncology, Inflammation, General Medicine, and Rare Disease.
EXPECTED CAREER ROADMAP
APPLICATION ADVISORY
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