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Specialist Quality Complaints

1 month ago

Ottawa, Canada Amgen Full time

**HOW MIGHT YOU DEFY IMAGINATION?**

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Specialist Quality Complaints

**Live**:
**What you will do**

Let’s do this. Let’s change the world. Amgen is seeking a Specialist Quality Complaints Owner and member of the Product Complaints and Surveillance team. The Product Complaints and Surveillance team owns and executes 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 Specialist conducts complex complaint investigations, determines corrective actions with their effectiveness and determines the steps necessary to ensure the proper level of control for product in distribution.

**Key Responsibilities**:

- Ensures quality of complaint records
- Applies analytical skills to evaluate complex situations using multiple sources of information
- Execution of regulatory and SOP requirements
- Anticipates and prevents potential issues with regulators
- Provides guidance and technical advice
- Escalates potential Quality issues to Management

**Win**:
**What we expect of you**

**Basic Qualifications**:
Doctorate degree

**Or**:
Master’s degree and 3 years of Quality / Manufacturing experience

**Or**:
Bachelor’s degree and 5 years of Quality / Manufacturing experience

**Or**:
Associate’s degree and 10 years of Quality / Manufacturing experience

**Or**:
High school diploma / GED and 12 years of Quality / Manufacturing experience

**Preferred Qualifications**:

- 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry
- Bachelor’s Degree in a Science Field
- Ability to oversee multiple projects simultaneously
- Ability to successfully manage workload to timelines
- Familiarity with basic project management tools
- Ability to negotiate a position after taking feedback from multiple sources
- Demonstrated ability to consistently deliver on-time, and high-quality results
- Ability to operate in a matrixed or team environment
- Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
- Ability to travel +/- 10% of time to domestic and international Amgen sites

**Thrive**:
**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

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

**for a career that defies imagination**

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

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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