Job Description

Career Category

Quality

Join Amgen's Mission to Serve Patients
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology
companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Sr Associate Quality Complaints

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What will you do?

Amgen is seeking a Sr Associate Quality Complaints owner and member of the Product Complaints and Surveillance team. The Product Complaints and Surveillance team owns 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 Sr. Associate conducts low to medium complexity complaint investigations and determines if complaint investigations require escalation for further investigation.

• Evaluates and ensures triaged product complaint records comply 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 complex situations using multiple sources of information
• Executes 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 deliverables within time and with expected quality, including (but not limited to) proactive written / in person communication, status updates, tracker & tool maintenance

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What we expect of you?

We are all different, yet we all use our unique contributions to serve patients. This role may require working in shifts or extended hours within the same shift.

Basic Qualifications:

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 to be able to understand & articulate technical concepts

Preferred Qualifications:

• 4+ years of quality and/or manufacturing experience in biotech, medical device or pharmaceutical industry
• Bachelor’s Degree in a Science Field
• Leadership skills
• 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 on-time, and high-quality results
• Ability to translate business and stakeholder feedback and requirements into accurate and efficient processes using clear language and format