Career Category

Quality

Job Description

What you will do

Let’s do this. Let’s change the world. In this vital role you will conduct low to medium complexity complaint investigations and determines if complaint investigations require escalation 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 complex situations using multiple sources of information

• Drives 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

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications:

• Master’s degree and 1 to 3 years of Quality experience OR

• Bachelor’s 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

• 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 collaborator feedback and requirements into accurate and efficient processes using clear language and format

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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