Collects samples for Environmental monitoring (EM) and Utilities monitoring (UM). Responsible for all sample collection and logistics as needed.Coordinates testing materials and supplies needed for testingPerforms Basic Microbiology laboratory testing following standard procedures for all samples, including but not limited to all in-process samples, raw materials, EM and utilities samples for Bioburden, Endotoxin, plate reading, and microbial identificationPerforms sterility testing, isolator qualification and routine operations and maintenanceSample and data entry into LIMS systemReviews general lab testing resultsTroubleshoots routine assaysGeneral laboratory support and laboratory maintenance in a cGMP laboratory including maintaining laboratory supplies needed for operations, maintenance of analytical instruments, purchasing and receiving of laboratory supplies (media, kits, etc.)Ensures CAPAs are being followed in the laboratory areasNotifies client management and assists with the initiation of events (such as deviations) in the quality systems
