Amgen Senior Associate Quality Assurance in Thousand Oaks, California
A biotechnology pioneer since 1980, Amgen has grown to be the world's largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. 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 role supports Amgen's Quality Assurance program under the Manufacturing Floor QA organization providing daily oversight of Cell Bank, Cell Culture, Purification, Drug Product Formulation/Fill, and Small Molecules production activities. Under general supervision, the role provides support and compliance oversight to MFG and F&E 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 class 1 nonconformances and CAPAs. Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion. The incumbent will also represent functional area quality for the Bulk Quality Assurance department in the execution of projects necessary to achieve departmental operational excellence goals and will work in a team matrix environment.
Bachelor's Degree and 2 years of Quality experience
Associate's degree and 6 years of Quality experience
High school diploma/GED and 8 years of Quality experience
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
Capable of making decisions independently and determining when to elevate to management, as appropriate in an environment that balances business need, quality and compliance risk
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
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.