Career Category

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.

QA Specialist, Incoming Quality - System Owner

Live

What you will do

Let’s do this! Let’s change the world!

In this vital role you will play a key role in the Quality team with a focus on Incoming Quality activities and system ownership. A key aspect of this role is to apply sophisticated thinking to ensure quality and compliance to GMP regulations for all IQA (Incoming Quality Assurance) operations. The Incoming Quality Area, is the warehouse area, owned by the QA team, where all materials needed for the manufacturing of the finished drug product are sampled, inspected, and dispositioned before being used in any GMP operation. This team works closely with the supply chain planning organization and supplier quality management to ensure timely dispositioning of the materials that are required for finished drug product manufacturing at the facility.

S/he will support all activities for the set-up of the new IQA area, administer timely commissioning/qualification of lab equipment/instruments and support successful execution of the method transfers using lean principles. S/he will support implementation of the Amgen Quality Management system (QMS) within the incoming QA area (e.g., Standard Operating Procedures (SOPs) creation, deviation management, change control, CAPA etc.). S/he will lead and direct other IQA and cross functional staff as an informed Subject Matter Expert (SME) in the Quality Assurance deliverables.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The outstanding professional we seek will have these qualifications.

Basic Qualifications:

Doctorate degree

Or

Master's degree and 3 years of Quality experience

Or

Bachelor's degree and 5 years of Quality experience

Or

Associate's degree and 10 years of Quality experience

Or

Highschool diploma / GED and 12 years of Quality experience

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, so we 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 maximize 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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