Specialist Quality Assurance- Drug Product

Thousand Oaks, CA, US
Mar 22, 2019
Required Education
Position Type
Full time
This position supports Amgen's Quality Assurance program under the Plant QA organization through providing oversight for the production of drug substance at Amgen Thousand Oaks. Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities & Engineering staff in the execution of their processes, procedures, and use of quality systems. Duties include electronic batch record review, batch record review, SOP and MP revision approval, work order approval, and quality approval of nonconformance, change control, and CAPA records. Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion. The Specialist will also provide support in the execution of projects necessary to achieve departmental operational excellence goals and will work in a team matrix environment.

Basic Qualifications:

Doctorate degree


Master's degree and 3 years of Quality experience


Bachelor's degree and 5 years of Quality experience


Associate's degree and 10 years of Quality experience


High school diploma / GED and 12 years of Quality experience

Preferred Qualifications:
  • Experience in drug product processing principles including aseptic manufacturing technique, formulation, filtration, isolator technology, lypohilization, and knowledge of sterile drug product related regulations.
  • 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.
  • Evaluating 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.

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.