Candidates in this role are responsible for the accurate and efficient execution of microbiological tests including aseptic processing of sterility tests in a cleanroom suite, particulate matter testing via the use of a laser particle analyzer or microscopic examination, endotoxin testing, or other microbiology pharmaceutical testing in accordance with established procedures. Candidates Will collect and present data in a well-reasoned and accurate manner and maintain the laboratory environment according to cGMP guidelines.Responsibilities:Preparing and performing microbiological tests on medical devices and pharmaceuticals as recommended by current USP, FDA, and AAMI/ISO regulations.Routine Quality Control of laboratory equipment, media, and microorganisms.Provide accurate test results to customers on a timely basis including but not limited to Bioburden, Limulus amoebocyte lysate (LAL) Sterility for Medical Devices, Off-Site Clean Room Validation and Monitoring, etc.Record test results accurately and legibly on all documents.Technical report writing including text, tables, graphs, and diagrams.Assist in the training of new Laboratory Technicians.Follow and perform process qualifications and validations for procedures and/or equipment.Maintain control of test samples including logging in, storage, tracking, and disposal.Monitor test status and conditions as described in Work Instructions and Operating Procedures.Routine maintenance of laboratory environment to include cleaning and troubleshooting.Report any deviations and/or nonconformities to Management.Suggest possible preventative and corrective measures to prevent future deviations and nonconformities.Inventory of laboratory supplies to maintain par levels.Perform onsite and offsite testing.Gowning and garbing for cleanroom settings.In cooperation with the Laboratory Manager, responsible for the qualification, maintenance, and calibration of critical equipment.Update procedures for improvement to methods.Assist with OOS, NI, CAPA, and Change Control processes in response to Laboratory issues.Driving a company car for offsite work, if applicable.Other duties as assigned.
