Develop and Coordinate Environmental and Sterilization Plans with full implementation of new and modified products- Environmental and Sterilization Validations- File, update and maintain Environmental and Sterilization records in accordance with current US and foreign regulations for Facility registrations, certification and licenses- Maintain and organize appropriate Environmental and Sterilization records to demonstrate compliance with applicable regulations- Perform Environmental and Sterilization contractor monitoring and audits.- Continuously improve Sterilization and Environmental processes and practices- Generate, coordinate and follow up any CAPA, NCMR or Complaint related to- Sterilization and Environmental activities.- Develop, implement and maintain the Environmental and Sterilization sampling plans- Serve as a safety administrator.- Customers communication on any item related to Sterilization or Environmental issues.- Other tasks related to the organization requested by Direct Supervisor.- Manage sterilization service provider to ensure they are complying to the latest regulatory requirements and current governed standard.**JOB RESPONSIBILITIES**:- Manage sterilization service provider to ensure they are complying to the latest regulatory requirements and current governed standard.- Supervise and support the internal sterilization process to ensure the latest regulatory requirements and current governed standard is adhered.- Manage the sterilization validation process including preparing and reviewing of protocol & report.- Supervision and organization of the environmental control to ensure the cleanroom / controlled room is working within specification.- Supervision and organization of the hygiene practices and microbiological control to ensure the practice is conform to requirement.- Supervise the investigation and action for the anomaly of the microbiological issues.- Supervise and manage the outsourced testing laboratory to ensure the test method is comply to requirement.- Leading/supporting non-conformance investigation activities derived from internal/external including risk assessment, root cause analysis, implementing corrective & preventive action, etc.- Identify and initiate improvement activities through analysis of data from quality records.- Ensure the periodic validation review is conducted in timely manner.- Support in internal and external audit process.- Execute supplier audit including generating audit plan, preparing audit report, follow up with supplier reply, etc.- Work with Supply Chain to ensure the Supplier Corrective Action Report issued to supplier is closed in timely manner.- Assist and report all microbiological and sterilization related matters to superior.**JOB REQUIREMENTS**:- At least **2 years' **working experience in **handing microbiological related task & sterilization process** in a manufacturing industry**, **preferably in **Medical Device industry**.- Have similar experience working in cleanroom environment.- Able to work in a team and under minimum supervision.- Strong interpersonal, analytical and problem-solving skills.- Initiative, proactive, resourceful, able to multi-tasks and work independently.- Good written and verbal communication skills in EnglishTipo de puesto: Tiempo completoSueldo: $713.54 - $1,700.00 al díaHorario:- Lunes a viernes- Turno de 10 horas- Turno matutinoPrestaciones:- Estacionamiento de la empresa- Seguro de gastos médicos mayores- Seguro de vida- Vales de despensaPuede trasladarse/mudarse:- 22704, Playas de Rosarito, B.C.: Trasladarse al trabajo sin problemas o planear mudarse antes de comenzar a trabajar (Obligatorio)Escolaridad:- Licenciatura terminada (Deseable)Experiência:- Micro y procesos de esterilización en una industria medica: 2 años (Obligatorio)- ISO 13485: 2 años (Obligatorio)- GMP y FDA 21 CFR Part.: 2 años (Obligatorio)Idioma:- Inglés (Obligatorio)Lugar de trabajo: Empleo presencialFecha de inicio prevista: 24/06/2024
