Qc Analyst Ii - Microbiology - Product Testing
Current• Execution of microbiological tests including but not limited to bioburden, endotoxins, growth promotion, sterility, particulate profiling, and microbial identification of bulk, raw materials, in-process material, components, and finished product• Review and data entry for testing results into the electronic data management systems• Perform laboratory investigations for out of specification and/or out of trend results in conjunction with management• Write change controls and work… Show more • Execution of microbiological tests including but not limited to bioburden, endotoxins, growth promotion, sterility, particulate profiling, and microbial identification of bulk, raw materials, in-process material, components, and finished product• Review and data entry for testing results into the electronic data management systems• Perform laboratory investigations for out of specification and/or out of trend results in conjunction with management• Write change controls and work orders for systems and instrumentation changes• Creation/revision of SOP’s and other documents required to support testing and ensure compliance• Participate in non-routine projects, validations and method development to meet departmental and individual goals• LIMS, SLIM, ELN, SDMS, MODA, SCADA, TrackWise Digital, Veeva Vault, ComplianceWire LMS Show less