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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-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.
Job Responsibility
Perform microbial assessments and other GMP documentation as required (reports, assessments, SOP revisions)
Support microbial and other QC laboratory investigations
Perform Microbiological testing to support GMP operations across ATO
Perform Microbiological sample and method qualifications including bioburden, microbial identification, sterility, and other microbiological assays as assigned
Perform testing and data review for compendia, non-compendia methods, and routine laboratory procedures
Generate complete, accurate, and concise laboratory documentation using electronic systems, such as LMES, LIMS, and laboratory notebooks
Operate and maintain specialized laboratory equipment and instrumentation
Perform general laboratory housekeeping activities and safety inspections
Maintain training compliance and proficiency
At all times, comply with safety guidelines, cGMPs and other applicable regulatory requirements
Requirements
High school/GED + 4 years of Quality experience OR Associate's + 2 years of Quality experience OR Bachelor's degree and 6 months of Quality, Microbiology or Operations experience
Master's degree
Nice to have
Professional work experience in a fast-paced, flexible GMP laboratory
Leadership ability, to assist with the daily/weekly schedule, routine and non-routine testing and sample collection questions and issues, and equipment troubleshooting
Experience supporting Environmental and Clean Utility Monitoring programs
Operation, maintenance experience with laboratory equipment
Ability to generate and revise methods, reports and SOPs within CDOCs
Demonstrated proficiency with electronic systems (LIMS, LMES, CIMS, CDOCS, etc.)
Ability to generate, update, triage, and close deviations and analytical test result assessments
Demonstrated understanding and use of Maximo and the ability to update and complete work orders
Ability to manage and lead Operational Excellence initiatives including 5S and Standard Work associated with the testing labs
Demonstrated written and oral communication skills, project management and presentation skills, and proven ability to manage priorities effectively
Demonstrated ability to be flexible and adaptable to support business needs
What we offer
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts