Amgen Senior Associate Quality Control: Microbiology 2nd shift in Woburn, Massachusetts
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.
As part of the Amgen’s Manufacturing Operations organization, our Amgen Woburn Manufacturing (AWM) site manufactures oncolytic virus based end-to-end drug substance and drug products for the global market. As such we continuously strive to be a leader in detailed execution to ensure we deliver our medicines to every patient, every time. Operational Excellence is at the core of how we do what we do with a continuous improvement approach, and a steadfast focus on safety, quality, and compliance.
Under general supervision, this position will perform routine procedures and testing in support of the Quality Control (QC) Microbiology Environmental Monitoring (EM) Lab.
Performing Environmental Monitoring in the Manufacturing plants
Performing Personnel Monitoring for gowning certifications
Documenting, computing, compiling, interpreting and entering data
Maintaining and operating specialized equipment
Initiating and / or implementing changes in controlled documents
Quality systems support, which may include ownership of Nonconformances, Analytical Result Assessments and Change Control records
Assisting the Laboratory Manager with daily management of the QC Microbiology Lab, including scheduling of daily activities, troubleshooting issues and ensuring adherence to sample due dates
Development, implementation, coordination and maintenance of laboratory improvements
Learn and comply with safety guidelines and Good Manufacturing Practices (cGMPs) / Code of Federal Regulations (CFRs) which includes, but is not limited to, the maintenance of training records, laboratory documentation, written procedures, building monitoring systems and laboratory logbooks
Bachelor’s degree and 2 years of Quality Control experience
Associate’s degree and 6 years of Quality Control experience
High school diploma / GED and 8 years of Quality Control experience
Previous experience in a regulated GMP environment
Experience in the following areas: QC Microbiology methods, Environmental Monitoring, Endotoxin testing, Growth Promotion testing, Water sampling, Bioburden testing and Result Reporting
Operation, maintenance, and troubleshooting experience with Environmental Monitoring equipment and instrumentation
Experience with Cleanroom gowning
Experience and training in aseptic technique
Experience using Laboratory Information Management System (LIMS)
Experience and knowledge of Data Integrity Requirements of Quality Control Systems
Proficient in Microsoft Office (e.g. Outlook, Word, Excel, PowerPoint)
Excellent problem-solving capabilities and attention to detail
Experience of collaboration within and across functional areas and outstanding customer service focus
Excellent written and verbal communication skills
We understand that to successfully sustain and grow as a global enterprise and deliver for patients — we must ensure a diverse and inclusive work environment.
Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission – to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
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.