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Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role.

Senior Associate Quality Assurance

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will, under general supervision, provide tactical support activities to Site Leaders across multiple Quality Systems and Processes. Participate in medium complexity transactional activities related to audit coordination and support program key activities, project management and Global Network SME on lower risk networks (e.g., document management, training, process/periodic monitoring report, visualization tools lead and validation).

Specific responsibilities include but are not limited to:

• Ensure quality systems and processes align with Operating Standards such as ESQ Audits, Raw Material ESQ KIPs for WCT-Smartsheet/Manages Approved Consultant Process and Form, and Master Data Changes).
• Understand, report, and identify key issues, priorities and opportunities of the External Quality/Supply organization and provide network resolutions.
• Support staff to resolve questions regarding subject matter expertise (SME) (e.g, Audit, Purchase Orders, Invoices, trending, data analysis, master data changes, periodic monitoring reports, visualization tools, Tier 0 and Tier 1 metrics to QMR/PMR/WCT).
• Prepare complete, accurate and concise documents process flows at CDOCS.
• Work/Contribute with teams to support achievement project landmarks (e.g., SME/Lead of ESQ Audit E2E Dashboard project, and tool that improve the monitoring and scheduling of audits and periodic monitoring reports).
• Able to identify and seek mentorship to implement changes in process for impacted areas.
• Seek outside resources as needed and select appropriate alternatives from defined options.
• Build productive internal/external relationships.

Win

What we expect of you

We are all different, yet we all use our outstanding contributions to serve patients. The Senior Associate QA professional we seek is an individual contributor with these qualifications.

The Basic Qualifications are:

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

Beyond that, the additional preferred qualifications are:

• Educational Background in Life Science or Engineering.
• Quality and manufacturing experience in biotech, service providers and suppliers, medical device or pharmaceutical industry within a GMP regulated environment
• Experience with SAP
• Basic project management skills experience.
• Ability to prioritize work and meet Amgen goals.
• Ability to adapt when changing priorities and requirements.
• General understanding of the manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes).

Thrive

Some of the vast rewards of working here

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.

• Full support and career-development resources to expand your skills, enhance your expertise, and improve your potential along your career journey
• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now

for a career that defies imagination

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

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