About this role
About the Role Amgen is seeking a Sr Associate Quality Complaints owner and member of the Product Complaints and Surveillance team. The team owns and implements the end-to-end global complaint process and management system, ensuring compliance with quality operating standards and procedures and translating market information to drive continuous improvement. What You'll Do
- Conduct low to medium complexity complaint investigations and determine if escalation is required.
- Evaluate and triage product complaint records to ensure compliance with applicable procedures.
- Own complaint records with basic investigations and ensure quality of records.
- Complete assigned assessments per applicable procedures.
- Apply analytical skills to evaluate complex situations using multiple sources of information.
- Execute the complaint process per SOP requirements.
- Own or manage the review/approval process flow in CDOCS of controlled documents, adhering to format, content, and style guidelines.
- Support management of assigned projects or tasks to achieve deliverables within time and with quality, including proactive written/in-person communication, status updates, tracker & tool maintenance. What We're Looking For
- Master’s degree OR Bachelor’s degree and 2+ years of Quality experience OR Associate’s degree and 6+ years of Quality experience OR High school diploma / GED and 8+ years of Quality experience.
- Fluency in verbal and written English.
- 4+ years of quality and/or manufacturing experience in biotech (preferred).
- This role may require working in shifts or extended hours within the same shift. Nice to Have
- 4+ years of quality and/or manufacturing experience in biotech (preferred). Compensation & Benefits
- Salary and benefits not disclosed in the posting.