Career Category

Quality

Job Description

The Sr. Associate Quality Assurance position supports Amgen’s Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Product manufacturing areas. Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities and Engineering staff in the execution of their processes, procedures, and use of quality systems. Duties include purposeful presence on the shop floor, electronic batch record creation, batch record review, SOP revision approval, work order approval, and quality approval of minor deviations and CAPA records. Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion. The Sr. Associate will also represent functional area quality for the Drug Product Quality Assurance department in the execution of projects necessary to achieve departmental operational goals and will work in a team matrix environment.

Basic Qualifications:

Master’s degree

OR

Bachelor’s degree and 2 years of Quality experience

OR

Associate’s degree and 6 years of Quality experience

OR 

High school diploma / GED and 8 years of Quality experience

Preferred Qualifications:

• Bachelor’s Degree in Biochemistry, Biology, Chemistry, or related science field
• Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and good documentation practices
• Experience managing projects through to completion meeting timelines.
• Ability to evaluate documentation and operations according to company procedures.
• Experience working with Quality Systems
• Strong organizational skills and ability to manage multiple tasks at one time
• Effective communication skills (both written and verbal)
• Demonstrated ability to work as both a team player and independently
• Display leadership attributes and drive improvement initiatives
• Solid understanding and application of aseptic behaviors and principles

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 advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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.

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.

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