Support the Microbiology Laboratory: Equipment preparation and sterilization/depyrogenation; Preparation of media; General laboratory cleaning; Preparation of specialty test samples; and Ordering of supplies. Perform Test Procedures: Perform self-contained sterility testing; Perform bioburden estimation of devices, components, and solutions; Perform endotoxin testing of devices, components, and solutions; and Perform validation of product test procedures. Perform Environmental Monitoring: Perform certification testing of cleanrooms (particle counts, air velocity, pressure differential, microbial count, air filter leak test). Documentation of laboratory procedures: Accurate record keeping of lab procedures performed and their results; and Archiving of lab records. Modification of controlled documents via the Change Order process. Troubleshooting/Brainstorm microbiological test procedures, cleanroom environmental disruptions, and sterilization cycles. Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
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Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
Number of Employees
5,001-10,000 employees