- 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
- that apply to Centerpiece for the activities that occur to be in compliance with international regulation.
- 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:
- Candidate must possess at least Degree in Microbiology or science related field or equivalent,
- At least 2 years’ working experience in handing microbiological related task & sterilization process in a manufacturing industry, preferably in Medical Device industry.
- Preferably candidate with good knowledge of ISO 13485, GMP and FDA 21 CFR Part.
- 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 English
Tipo de puesto: Tiempo completo
Sueldo: $1,200.00 - $1,900.00 al día
Beneficios:
- Estacionamiento de la empresa
- Seguro de gastos médicos mayores
- Seguro de vida
- Vales de despensa
Puede trasladarse/mudarse:
- 22706, Rosarito, B.C.: Trasladarse al trabajo sin problemas o planear mudarse antes de comenzar a trabajar (Obligatorio)
Escolaridad:
- Licenciatura terminada (Deseable)
Experiencia:
- 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:
Lugar de trabajo: Empleo presencial
