Senior Associate Quality Complaints

In this vital role, you will own and implement the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement.

The Senior Associate conducts low to medium complexity complaint investigations and determines if complaint investigations require issue for further investigation.

• Evaluates and ensures triaged product complaint records align with applicable procedures.
• Evaluates and owns complaint records with basic investigations.
• Ensures the quality of complaint records.
• Completes assigned assessments per applicable procedures.
• Applies analytical skills to evaluate sophisticated situations using multiple sources of information.
• Implements the complaint process per SOP requirements.
• Owns or manages the review / approval process flow in CDOCS of controlled documents; while adhering to format, content, and style guidelines, considering usability, and ensuring accuracy, consistency, and quality according to templates and style guide.
• Supports the management of assigned projects or project tasks to achieve agreed results within time and with encouraged quality, including (but not limited to) proactive written / in-person communication, status updates, tracker & tool maintenance.

What we expect of you

Basic Qualifications :

Preferred Qualifications :

Skills Required

Sop, manufacturing processes , Quality Control, Quality Assurance, Qms, Manufacturing