Specialist Quality Assurance


Youve worked hard to become the professional you are today and are now ready to take the next step in your career.

How will you put your skills, experience and passion to work toward your goals?

At Amgen, our shared missionto serve patientsdrives all that we do.

It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide.

Come do your best work alongside other innovative, driven professionals in this meaningful role.

Specialist Quality Assurance Live What you will do Lets do this.

Lets change the world.

In this vital role you will provide Quality oversight functions related to the manufacture of Bulk Drug Substance at Amgen Rhode Island.

Responsibilities include the following: Lead and project manage complex investigations for major and critical deviation events associated with Amgens manufactured products, raw materials, Quality Control systems and processes, including manufacturing investigations as needed.

Provide Quality oversight for change control records for analytical method revisions and equipment installation and validation, as needed.

Supporting QC Equipment Life Cycle Management Program.

Own minor deviation records, CAPAs, and EV records as required.

Assist with the management of Reference Standards and Critical Reagents.

Supports inspection readiness activities across Quality Control, and site audits and inspections.

Win What we expect of you We are all different, yet we all use our unique contributions to serve patients.

The expert professional we seek is an outstanding communicator with these qualifications.

Basic Qualifications: Doctorate degree Or Masters degree and 3 years of Quality experience Or Bachelors degree and 5 years of Quality experience Or Associate degree and 10 years of Quality experience Or High school diploma / GED and 12 years of Quality experience Preferred Qualifications: Previous experience in Quality Systems (Investigations, CAPAs, EVs, and Change Controls).

Project management skills.

Proficiency in Excel, Word, and Power Point.

Strong interpersonal skills.

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

Statistical knowledge, ability to trend data and apply corrective actions to interpretations of complex data sets.

Exposure to Operational Excellence initiatives including Lean Manufacturing and 5S.

Previous experience in a regulated GMP environment.

Exposure to regulatory agency inspections (or participation in internal audits).

Experience with analytical laboratory testing and laboratory equipment to support technical discussions.

Experience managing Reference Standards and/or critical reagents.

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 Plancomprising health, finance and wealth, work/life balance, and career benefitswith 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 Join Us If you’re seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you’ll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics.

Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win.

Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

Please contact us to request accommodation.

Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment.

In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance.

Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

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