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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.

Sr. Associate Quality Control

Shift: Tuesday through Friday 7AM to 5PM

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will be responsible for activities including microbiological & analytical testing, sample and data management and equipment, instrumentation operation and maintenance, sample and equipment troubleshooting, assistance with reviewing and authorizing documents and samples, and provide leadership on the QC for Mfg Operations Team B while performing in a highly dynamic, team environment.

Perform sample collection, sample handling, and Microbiological testing to support GMP operations across ARI. Perform testing and possible data review for compendia, non-compendia methods, and routine laboratory procedures. Generate complete, accurate, and concise laboratory documentation using electronic systems, such as LMES, LIMS, and laboratory notebooks. Operate and maintain specialized laboratory equipment and instrumentation. Participate in QC laboratory investigations and audits as necessary. Lead the team to ensure the daily/weekly Level and Flow for QC testing is performed. Perform general laboratory housekeeping activities. Maintain training compliance and proficiency At all times, comply with safety guidelines, cGMPs and other applicable regulatory requirements.

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:

Master's degree

OR

Bachelor’s degree and 2 years of Quality experience

OR

Associate’s degree and 6years of Quality experience

Or

High school diploma / GED and 8years of Quality experience

Preferred Qualifications:

• Professional work experience in a fast-paced, flexible GMP laboratory.

• Leadership ability, to assist with the daily/weekly schedule, routine testing and sample collection questions and issues, and equipment troubleshooting.

• Experience testing microbiological, utility, and raw material samples.

• Operation, maintenance experience with laboratory equipment.

• Ability to generate and revise methods and SOPs within CDOCs.

• Demonstrated proficiency with electronic systems (LIMS, LMES, CIMS, Trackwise, etc.).

• Ability to generate, update, and close deviations and analytical result assessments in Trackwise.

• Demonstrated understanding and use of Maximo and the ability to update and complete work orders.

• Ability to manage and lead Operational Excellence initiatives including Level and Flow, 5S, and Standard Work associated with the testing labs.

• Demonstrated written and oral communication skills, project management and presentation skills, and demonstrated ability to manage priorities effectively.

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

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 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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