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

Live

What you will do

Let's do this! Let's change the world! The Specialist QA position will be responsible for commercial product supply, secondary packaging & labeling oversight, incoming raw material inspection & release, logistic service provider & transportation service provider oversight, Quality Management System Process alignment, audit & inspection execution, validation oversight, and site improvement activities at the Louisville Distribution Center (LDC).

Responsibilities:

Working independently, the individual will be responsible for, but not limited to the following:

• Perform receipt, manufacturing, storage, distribution, and facilities & engineering documentation review to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations

• Perform cGMP process, procedure, document and record review, and approval, including but not limited to deviations, CAPAs, change controls, risk assessment, and validation records. May also support execution of these tasks

• Ensure operations align with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Distribution Practices, Good Documentation Practices, and Safety

• Support Labeling and Packaging Operations including incoming raw material inspection and release, manufacturing oversight, batch record review, and product release

• Represent LDC on Global Quality Management System (QMS) Process Collaboration teams

• Provide input and influence global decisions related to the QMS

• Monitor and drive improvements to the health of the QMS

• Provide leadership updates regarding the health and initiatives relating to the QMS at site management reviews

• Provide logistic service provider and transportation service provider oversight

• Represent the Quality Unit during audits and inspections and directly interact with regulatory agencies during on-site inspections

• Support internal/external audits and inspections as part of the audit/inspection team

• Perform routine Quality Assurance assessments of site operations and provide direct oversight

• Provide quality expertise and guidance to operational staff and within cross functional Amgen teams

• Drive operational improvement initiatives, programs, and projects

• Develop solutions that are thorough, practical, and consistent with functional objectives

• Perform additional duties as specified by management

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 will have these qualifications.

Basic Qualifications

Doctorate

Or

Master’s degree and 3 years of experience

Or

Bachelor’s degree and 5 years of experience

Or

Associates’ degree and 10 years of experience

Or

High School Diploma/ GED and 12 years of experience

Preferred Qualifications

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

• Previous QA oversight of manufacturing, validation, and facility and engineering activities

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

• Direct Validation experience with pharmaceutical or biopharmaceutical processes

• Ability to evaluate compliance issues and interact with regulatory inspectors

• Experience and training in CDOCS, TrackWise, Maximo, SM LIMS, ERP

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

• Experience leading and/or managing teams

• Direct drug substance and/or drug product experience

• Ability to solve complex problems and make scientific risk-based decisions

• Experience representing Amgen while interacting with representatives of regulatory agencies

• Demonstrated proficiency using Excel, Word, and PowerPoint

• Good written and oral communication

Thrive

Some of the vast rewards of working here

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, 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.

careers.amgen.com