Associate Quality Control
About the role
Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Responsibilities
- Perform routine laboratory procedures
- Perform routine analytical testing
- Document, compute, compile, interpret and enter data
- Maintain and operate specialized equipment
- Initiate and/or implement changes in controlled documents
- Learn and comply with safety guidelines and cGMPs/CFRs, including maintenance of training records, laboratory documentation, written procedures, building monitoring systems and laboratory logbooks
- Perform testing and data review for compendia, non-compendia methods, and routine laboratory procedures (bioburden, endotoxin, sterility, growth promotion, microbial ID testing, additional microbiological testing)
- Perform bioburden, endotoxin, and sterility validation testing for product, raw materials, and component sample types
- Initiate deviations and TRAs for quality events in DQMS
- Draft and review documents in CDOCS, as needed
- Perform gowning monitoring certification sampling in the manufacturing grade 5 environment
- Use testing and data review within automated sampling systems, such as LIMS, L