Specialist QA

HOW MIGHT YOU DEFY IMAGINATION?

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role.

Live

What you will do

Lets do this! Lets change the world!

• Provide QA Systems expertise and QA support to the Product Quality organization (PQ and Stability) by working within a team environment.

• Provide Product Quality QA support to one or more of Amgen's clinical and commercial products by working directly with Product Quality Leaders and Principal Product Quality Leaders on QA related tasks.

• Responsible for QA related tasks in support of both clinical and commercial Product Quality Leaders, including ownership, QA review and approval of documents (Protocols, Reports, Specifications, IPCs, Annual Product Review, etc.), and execution of transactions (Owner and/or QA Contact) in relevant GMP systems (EDMQ, Change Control, Deviation/CAPA, etc.) and may include additional business process support.

• Additionally, support of audits/inspections, APR management, and other processes as required.

• Play a role in supporting/facilitating continuous improvement initiatives intended to increase Quality systems efficiencies within and outside of the PQ organization.

• Interact with other functional areas within Amgen such as Corporate Quality, International Quality, Quality Control, Regulatory, Process Development, Site Quality Assurance, Supply Chain etc.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The vital attribute professional we seek will have these qualifications.

Basic Qualifications:

Doctorate Degree

OR

Master's Degree & 3 years of Quality, Operations, Scientific, or Manufacturing experience

OR

Bachelor's Degree & 5 years of Quality, Operations, Scientific, or Manufacturing experience

OR

Associate's degree & 10 years of Quality, Operations, Scientific, or Manufacturing experience

OR

High school diploma/GED & 12 years of Quality, Operations, Scientific, or Manufacturing experience

Preferred Qualifications:

• Familiar with quality, compliance and regulatory requirements for clinical and/or commercial products (large and/or small molecule).

• General understanding of biopharmaceutical bulk and drug product development and manufacturing and general knowledge of cGMPs.

• Working knowledge of Amgen Quality systems (EDMQ, NC/CAPA, Change Control, etc.).

• Quality Assurance experience reviewing and approving cGMP documentation (Protocols, Reports, Specifications, SOPs, etc.).

• Experience owning Change Control records.

• Experience owning NC/CAPA records and participating in and/or leading investigations.

• Experience working on a cross-functional team in a matrix environment and strong project management skills.

• Excellent written and verbal communication skills, including facilitation and presentation skills.

• Competency in interacting with Senior Management.

• Strong organizational skills and the ability to manage and prioritize multiple/competing tasks and deliverables.

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 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

#Operations21Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your 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 a 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 an accommodation.

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.