Sr. Associate Quality Complaints

Career Category

Quality

Job Description

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

.