Senior Associate - Quality Complaints

What you will do

In this vital role you will own and implements 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 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 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

Basic Qualifications:

• Masters degree and 1 to 3 years of Quality experience OR
• Bachelors degree and 3 to 5 years of Quality experience OR
• Diploma and 7 to 9 years of Quality experience

Preferred Qualifications:

• Quality and/or manufacturing experience in biotech, medical device or pharmaceutical industry
• Bachelors Degree in a Science Field
• Ability to successfully manage workload to timelines
• Familiarity with basic project management tools
• Ability to operate in a matrixed or team environment with site, functional, and senior management leadership
• Experience in driving decision making by using the DAI principles
• Understanding of quality and industry requirements/expectations of a QMS
• Understanding of the applicable manufacturing/testing processes (i.e., API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
• Ability to negotiate a position after taking feedback from multiple sources
• Demonstrated ability to lead functional teams, consistently deliver timely, and high-quality results
• Ability to translate business and key collaborator feedback and requirements into accurate and efficient processes using clear language and format