Amgen Specialist Quality Assurance in Woburn, Massachusetts
Under minimal supervision, the Quality Assurance Specialist will be responsible for activities associated to Environmental and Critical Utilities Monitoring Program, including but not limited to trend analysis, laboratory investigations, and change control in a dynamic team environment.
Provide technical expertise in environmental and utility monitoring
Author technical documents (e.g. Environmental/Utilities Quarterly Reports)
Perform trend analysis of generated environmental and utility monitoring QC data Lead laboratory investigations and audits
Maintain training compliance and proficiency
Comply with safety guidelines, cGMPs and other applicable regulatory requirements
Doctorate degree OR
Master's degree and 3 years of Quality experience OR
Bachelor's degree and 5 years of Quality experience OR
Associate's degree and 10 years of Quality experience OR
High school diploma / GED and 12 years of Quality experience
Previous experience in a regulated GMP environment
Experience with (or strong knowledge of) 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 in audit settings.
Demonstrated statistical knowledge, ability to trend data and apply corrective actions to interpretations of complex data sets
Demonstrated technical writing skills within a highly regulated environment
Demonstrated investigational and problem solving skills related to nonconforming events
Exposure to Operational Excellence initiatives including Lean Manufacturing and 5S
Exposure to regulatory agency inspectors (or participation in regulatory agency audits)
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.