Qa Specialist - Digital Qa/Is Validation

Career Category

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.

Quality Assurance Specialist

Reporting to the Senior Manager Quality, the QA specialist for the new Amgen Advanced Assembly and Final Product Operation facility will provide quality oversight support of the design, installation, commissioning & qualification and process qualification of the new facility and equipment. QA specialist will also support implementation of the Amgen Quality management system into the new facility. This can cover a wide range of quality processes that drive and govern operations in manufacturing, warehousing and quality assurance (e.g. deviation management, disposition, change control etc.). Once the site is operation, the QA specialist will also provide quality oversight for manufacturing.

This role will require local presence at the New Albany facility near Columbus, Ohio. Hybrid option may be considered.

Live

What you will do

Let’s do this! Let’s change the world! At Amgen, we are committed to being science-based and follow a continuous learning approach to advancing science, driving discovery and igniting innovation that works to help reduce disease. It is in this context that we endorse an inclusive and diverse workforce that helps fuel scientific innovation and problem solving, leading to better scientific solutions that benefit both patients and society.

In this vital role you will be responsible for leading and directing cross functional staff as an informed Subject Matter Expert in the Quality deliverables under general supervision. A key aspect of this role is to apply problem solving skills to ensure quality and compliance to GMP regulations for all area operations and associated processes. Duties include will provide Quality oversight of the development and implementation of the digital advancement opportunities for the new facility and will lead the development of the digital Quality strategy for the new facility and coordinate effective implementation of that strategy.

Responsibilities:

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Quality professional we seek is a dynamic, flexible and driven individual with these qualifications.

Basic Qualifications:

Doctorate degree

OR

Master’s degree and 3 years of Quality and/or Manufacturing experience

Or

Bachelor’s degree and 5 years of Quality and/or Manufacturing experience

Or

Associate’s degree and 10 years of Quality and/or Manufacturing experience

Or

High school diploma / GED and 12 years of Quality and/or Manufacturing experience

Preferred Qualifications:

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.

The annual base salary range for this opportunity in the U.S. is $102,624 - $121,712.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

Apply now

for a career that defies imagination

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

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Salary Range