Microbiology Technician I

As Microbiology Technician I you will be responsible to support environmental control activities, executing environmental routine testing for viable and non-viable particles for air and product contact surfaces follow quality system and in compliance with Good manufacturing practices

Main Job Duties/Responsibilities:

• Follow all Good Manufacturing Practices and SOP's as defined by policies, practices and procedures to insure that FDA, MDD and ISO regulations and quality standards are met.
• Support and execute validation process for microbiological methods and cleanroom monitoring.
• Participate of the internal and extemal audit process
• Maintain all records according to established policies, practices and procedures.
• Monitor and perform routine environment microbiological control.
• Train and supervise the microbiology technician from external microbiology (suppliers) during environmental monitoring testing.
• Track and trend environment control monitoring results, identify excursions and notify this to the Microbiology Coordinator.
• Ensure that equipment used for microbiology analysis are calibrated and deliver on time the equipment to the calibration area.
• Ensure that all purchase order and invoices required for environmental control testing are on time.
• Archive all environmental monitoring records. Ensure that all required materials such binders, etc are available on site, perform internal requisitions for office supplies.
• Participate on the new employee onentation program.
• Coordinate and collect environmental controlled data for site clean rooms.

Knowledge / Education:

• Microbiology or Quality Technician. Biotechnology, Microbiology and Biology Bachelor degree is a plus.
• Microsoft office basic knowledge is required
• Bilingual English/Spanish - Basic-Intermediate English level.
• Basic knowledge of Minitab statistical software is a plus.

Work Experience:

• 0 to 2 year of experience within the medical device or pharmaceutical in the monitoring and control of clean room environments field.

Skills / Competencies:

• Ability to handle and operate environmental control and microbiology equipment.
• Focus on details, priorities management.
• Analytical and organized person
• Maintain effective working relations with all departments.
• Proactive
• Customer onented
• Ability to work independently and follow both verbal and written instructions
• Effective planning and time management
• Decision making
• Analytical
• Innovative