Career Category

Quality

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Senior Associate Quality Complaints

What you will do

Let’s do this. Let’s change the world. In this vital role you will 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 figures out if complaint investigations require critical 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 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

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 optimally handle 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 look after 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 driven and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now

for a career that resists creativity

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

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