Amgen Specialist Quality Assurance in Thousand Oaks, California

Job Summary

This QA Specialist role is responsible for initiating, coordinating and completing all levels of product complaint investigations.

Responsibilities include:

  • Initiate, coordinate and complete product complaint investigations

  • Interact with intake agents, other Amgen sites and business partners to ensure complaint process is followed

  • Reconcile reported product complaints to ensure accurate entry

  • Perform return sample coordination and ensure all mandatory assessments are complete

  • Archive documents related to product complaints

  • Alert quality management of quality, compliance, supply and safety risks

  • Supporting Continual Improvement initiatives, programs and projects as well as the Audit and Inspection process

Additionally, this role is responsible for performing site process lead (SPO) responsibilities which include communicating and presenting information to the product complaint trending network as well as site management review.

Basic Qualifications

Doctorate degree

OR

Master's degree and 3 years of Life Sciences experience

OR

Bachelor's degree and 5 years of Life Sciences experience

OR

Associate's degree and 10 years of Life Sciences experience

OR

High school diploma / GED and 12 years of Life Sciences experience

Preferred Qualifications

  • 2+ years of quality assurance or manufacturing experience in a GMP pharmaceutical or medical device industry

  • Self-motivated, attentive to details and able to prioritize and meet deadlines

  • Strong teamwork ability

  • Basic statistical mathematical skills including the ability to trend data

  • Basic project management skills

  • Independently understand, follow and implement instructions

  • Strong word processing, database and spreadsheet application skills

  • Strong organizational skills with the ability to manage multiple projects or assignments

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.