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.

Specialist QA - Administrative Shift

Live

What you will do

Let’s do this. Let’s change the world. The Quality Assurance Specialist will be responsible for PQA Off the Floor support and activities. This team is a centralized team supporting AR5, AR30 and the entire ARI. The team provides coaching, mentorship and guidance to Manufacturing, Quality Control, Process Development, Supply Chain, Facilities & Engineering and IS staff regarding quality systems and compliance.

Responsibilities include the following:

• Provide Quality oversight to Major Deviations, Change Controls, CAPAs/EVs, New Product Introductions (NPIs), Product Re-Introductions (PRIs) and Master Batch Records (MBRs) to ensure that operations products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.

• Ensure that changes that could potentially impact product quality are assessed according to procedures.

• Ensure that Facilities, Equipment, Materials, Manufacturing processes, Procedures and Products align with cGMP practices as well as other relevant regulations.

• Deliver Quality oversight to Document Management Systems records (CDOCs and GDMS)

• Establish and enable LEAN practices.

• Drive operational improvement initiatives and projects.

• Support Audits and Inspections

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 candidate with these qualifications.

Basic Qualifications

Doctorate degree

Or

Master’s degree and 3 years of Quality, Manufacturing, Process Development or Process Engineering experience

Or

Bachelor’s degree and 5 years of Quality, Manufacturing, Process Development or Process Engineering experience

Or

Associate’s degree and 10 years of Quality, Manufacturing, Process Development or Process Engineering experience

Or

High school diploma / GED and 12 years of Quality, Manufacturing, Process Development or Process Engineering experience

Preferred Qualifications

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

• Experience in QA oversight of manufacturing, analytical and engineering activities

• Experience in investigations, change controls, and CAPAs processes system knowledge

• Ability to evaluate compliance issues and interact with regulatory inspectors

• Experience and training in Trackwise, CDOCS, Maximo, LIMS

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

• Direct bulk drug substance and drug product experience

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

• Ability to problem solve and make scientific risk-based decisions

• Demonstrated proficiency using Excel, Word, Power Point, Smartsheet and Teams

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 maximize your potential along your career path

• 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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