Microbiology Lab Technician II

About the role

A Microbiology Laboratory Technician (I, II, III) works under limited supervision of the Quality Assurance or Sterility Assurance Organization and is responsible for providing support and leadership to the QA or SA Team and the Product and Environmental Monitoring Programs to achieve quality, efficiency, and cost targets, while ensuring compliance to all applicable standards.

Responsibilities

• Follow all procedures and work instructions pertaining to product monitoring
• Managing all documentation pertaining to product testing
• Preparation of product samples used for testing by physical manipulation of product samples under aseptic conditions
• Packing and shipping product samples to contract laboratories
• Obtaining test reports and analyzing results
• Maintain laboratory equipment and supplies for product monitoring
• Maintain accurate records pertaining to product monitoring to verify that required samples have been collected, processed and dispersed to appropriate testing laboratories
• Maintain communication between product testing laboratories to ensure timely testing and accuracy of product samples
• Provide support as needed to manufacturing operations to determine the root cause of product monitoring failures
• Provide support in creating and maintaining microbiology laboratory procedures and governing documents pertaining to product monitoring
• Prep of biological indicators for the use in customer EO sterilization
• Follow all procedures and work instructions pertaining to environmental monitoring
• Managing all documentation pertaining to environmental monitoring
• Coordinate and execute environmental monitoring, which includes but not limited to viable air and surface testing and non-viable air testing.
• Participate in microorganism evaluation(s).
• Compile, review and verify environmental monitoring testing results
• Complies with all water testing procedures
• Complies with all safety procedures and requirements for testing and testing areas
• Provide support in creating and maintaining microbiology laboratory procedures and governing documents pertaining to environmental monitoring
• Maintain communication between environmental monitoring testing laboratories to ensure timely testing and accuracy of samples
• Responsible for communicating business related issues or opportunities to next management level
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental and Quality Assurance practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Complies with any applicable Legal Hold notices
• Serve as a resource for quality issues and initiatives
• Participate in document and process improvements, including but not limited to data collection, document change controls, nonconformances, audit findings and additional training as required
• Comply and follow all procedures within the company security policy and company safety and quality programs
• Provide materials, documentation, communication or service to customers in a timely manner
• Maintain adherence to assigned training curriculum(s)
• Assist with internal and external audits
• Flexibility to adjust and rotate