Senior Associate QA

This role supports Amgen's Quality Assurance program under the Manufacturing Floor QA organization providing daily oversight of the Biosafety Development Lab, Cell Bank, and Pilot Plant (Cell Culture and Purification) 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, paper batch record review, SOP and MP review/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.

Basic Qualifications:

Master's Degree

OR

Bachelor's Degree & 2 years of Quality experience

OR

Associate's degree & 6 years of Quality experience

OR

High school diploma/GED & 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
• 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 thatbalances business need, quality and compliance risk
• Experience working with Quality Systems

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.