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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.

Specialist Quality Control

Live

What you will do

Let’s do this. Let’s change the world. In this integral role, the Quality Control Specialist 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 Microbiology team as well as technical/testing support for the QC for MFG testing teams. The staff of the QC Microbiology group perform in a highly dynamic, collaborative environment.

• Perform Microbiological testing to support GMP operations across ARI.

• Perform Microbiological sample and method qualifications including endotoxin, bioburden, qPCR, and other microbiological assays as assigned.

• Support and perform QC laboratory investigations and audits as necessary. Support and document trending analysis, validation protocols/reports, and change controls.

• Perform testing and 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. Own and document QC laboratory investigations, deviations, and audits as necessary.

• Lead the team to ensure the daily/weekly Level and Flow for testing is performed.

• Perform general laboratory housekeeping activities and safety inspections Maintain training compliance and proficiency.

• At all times, follow 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 professional with 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

• High school diploma / GED and 12 years of Quality experience

Preferred Qualifications:

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

• Leadership ability, support routine and non-routine testing, method and equipment troubleshooting.

• Ability to generate, investigate, and close deviations and analytical result assessments in Trackwise (Electronic Database for Capturing Investigations).

• Ability to generate and document validation protocols and reports.

• Ability to evaluate data for trends and document corrective actions.

• Experience performing microbial test methods including but not limited to endotoxin, bioburden, growth promotion, sterility, qPCR, and mycoplasma.

• Operation, maintenance experience with laboratory equipment.

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

• Demonstrated proficiency with electronic systems capturing consumables, testing procedures, results, and investigations (LIMS, LMES, CIMS, Trackwise, etc.).

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

• Demonstrated understanding and use of Maximo (Work order System)

• 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 proven ability to effectively prioritize tasks

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

Thrive

Some of the vast rewards of working here

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like sophisticated human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

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, 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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