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Job Description
Summary of Duties and Responsibilities / Resumen de funciones y responsabilidades: Monitor the controlled environment room, laundry, laminar flow hoods, air and water systems. Coordinate routine microbiology analysis with external laboratories. Coordinate with vendors such as sterilizers and external microbiology laboratories, for different special testing requirements. Support sterilization projects. Support/plan/execute cost and/or time effective continuous improvement initiatives for the Microbiology Lab and the routine activities performed. Plan and/or executed microbiological validations. Plan, coordinate or perform the dose audits and bioburden testing. Support the sterilization process requalifications or/and Annual Sterilization Assessment. Support and execute assessments related to sterilization processes (if applicable). Support Microbiology investigations related to NCEs, IACAs and CAPAs, etc. Product release support regarding events related to sterilization param...