Associate Quality Complaints
Core
Own and implement the end-to-end global complaint process and management system, ensuring compliance with quality operating standards and translating market information to drive continuous improvement.
Role type
Associate Quality Complaints Specialist
Builds
Global complaint management system and compliant quality processes
Domain
Biotechnology / Pharmaceutical Quality Management
Required skills
Product complaint investigation, Quality Management System (QMS) knowledge, Process adherence, Record evaluation and closure, Controlled document management, Project task support
Preferred skills
Manufacturing experience, Matrixed environment navigation, Manufacturing/testing process understanding, Process management systems proficiency, MS Office applications
Technologies
Amgen CDOCS, Amgen Learning Management System (LMS), Microsoft Word, Microsoft Excel
Responsibilities
Evaluate and ensure triaged product complaint records stay in sync with applicable procedures, Evaluate and manage customer feedback records to closure, Evaluate records that have been determined to be voided and complete the void process, Own records with limited information, Complete assigned assessments per applicable procedures, Ensure quality of complaint records
Seniority
Mid-level, hands-on IC