Senior QC Microbiologist

Perform sterility, endotoxin, pH and osmolality testing on raw materials, drug substance, and drug productPerform gram stains, sub-culturing of isolates, growth promotion testing, and general cell cultureCoordinate, schedule, and execute testing based on manufacturing schedulesDirect performance in Aseptic Processing Media Fills and perform support testing, including visual inspectionMaintain housekeeping and equipment maintenance including organization, cleanliness, and logbooksAssist the Quality Control department in daily operations, as neededAuthor and revise QC SOPs and change controls as necessary to maintain complianceAuthor and execute qualification protocols and reports for microbiological assaysPerform timely response to Out of Specification (OOS) results, including notification to area management. Perform and document laboratory investigations to ensure that potential problems and root causes are identified, impact assessed and actions to prevent recurrent are considered implemented. Execute associated CAPA.Ensure data integrity is maintained for all applications, programs, and executed work. Ability to document all work using Good Documentation Practices and ALCOA principles.Troubleshoot and analyze nonconforming data. Completion of thorough investigations to ensure that potential problems and root causes are identified, impact assessed and actions to prevent recurrence are considered and implemented.Perform internal audits and GEMBA walk-throughs of laboratory areas to maintain complianceCommunicate with the individual Operations Departments (Manufacturing, Quality Assurance, Facilities) to ensure that Company objectives are met on schedulePerform viable and non-viable environmental monitoring in support of Manufacturing and Quality Control in the form of air testing, surface testing, personnel testing and particulate monitoring, inside the aseptic clean rooms, as necessaryOversight of critical processing steps performed by Manufacturing during aseptic product manufacture, ensuring accuracy of steps performedTraining of other employees as necessary