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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.

Associate Quality Assurance

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will be responsible for Quality On the Floor in support of Manufacturing activities. This position provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements and deviations. This is a rare opportunity to foster a strong partnership and learning environment between Manufacturing and Quality staff.

Amgen’s Quality Assurance On-the-Floor position Shift 4 - 3 days a week Saturday through Monday 7am – 7pm

Responsibilities include the following:

• Responsible for providing Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations.

• Perform and document scheduled quality oversight activities.

• Perform review and approval of electronic batch records, SOPs, minor deviations and associated documentation.

• Enable LEAN practices.

• Oversee and provide mentorship during on-the-floor analytical testing.

• Ensures that deviations from established procedures are investigated and documented per procedures.

• Ensures that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.

• Alerts senior management of quality, compliance, supply and safety risks.

• Completes required assigned training to implement required tasks.

• Participate in operational improvement initiatives, programs and projects.

• Complies with safety guidelines, cGMPs and other applicable regulatory requirements at all times.

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 is a hard worker with these qualifications.

Basic Qualifications

Master or Bachelor's degree in Life Sciences

Or

Associate's degree and 4 years of Quality, Manufacturing, Validation, Process Development or Process Engineering experience

Or

High School diploma/GED and 6 years of Quality, Manufacturing, Validation, Process Development or Process Engineering experience

Preferred Qualifications

• Scientific degree in Life Sciences or Physical Sciences or Applied Engineering or Manufacturing Technologies

• Previous QA oversight of manufacturing, analytical or engineering activities

• Experience in investigations, system knowledge

• Demonstrated experience with electronic systems (CDOCs, Trackwise, Maximo, LIMS)

• Experience in managing multiple, competing priorities in a fast-paced environment

• GMP industry experience, such as Direct bulk drug substance, drug product, or medical devices

• Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with capability to communicate and collaborate effectively with technical and senior management staff

• Ability to partake in solving sophisticated problems with partners and make scientific risk-based decisions

• Demonstrated proficiency using Excel, Word and Power Point.

• Validated ability to be flexible and adaptable to support business needs.

Thrive

Some of the vast rewards of working here

As we strive 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, improve 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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