Amgen Senior Associate Quality Assurance in Woburn, Massachusetts
Responsible for providing Quality oversight to ensure that products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP) and other applicable regulations
Ensure facilities, equipment, materials, processes, procedures and products comply with cGMP practices and other applicable regulations.
Ensure raw materials and components, bulk drug substances, bulk drug products, and finished product for assigned areas meet GMP requirements.
Ensure the Quality unit provides review, approval and tracking of cGMP processes, procedures, assays, documents and records, including non-conformances, CAPAs, change control records and validations.
Responsible for changes that could potentially impact product quality are assessed according to procedures.
Ensure that deviations from established procedures are immediately triaged, investigated and documented per procedures.
Production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
Ensure that GMP functions are periodically audited to assess compliance to cGMP regulations and to identify potential risks.
Alert senior management of significant quality, compliance, supply and safety risks.
Perform AQL for Visual Inspection
Release of gases, cell banks and labels.
Oversight the Aseptic Processing filling and provide advice and guidance during the process.
Master's degree OR
Bachelor's degree and 2 years of Quality experience OR
Associate's degree and 6 years of Quality experience OR
High school diploma / GED and 8 years of Quality experience
Previous experience in QA, Validation, or compliance areas
Aseptic processing experience (i.e. Environmental qualification, Media fills)
Experience in batch record review
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.