Amgen Specialist Quality Assurance in Thousand Oaks, California
This QA Specialist role is responsible for initiating, coordinating and completing all levels of product complaint investigations.
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.
Master's degree and 3 years of Life Sciences experience
Bachelor's degree and 5 years of Life Sciences experience
Associate's degree and 10 years of Life Sciences experience
High school diploma / GED and 12 years of Life Sciences experience
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.