Senior Microbiologist
STAAR Surgical · Monrovia, California, US
MAIN JOB RESPONSIBILITIES / COMPETENCIES 1. Develop and execute plans to expand QC laboratory capabilities for microbiology, to include, but not limited to:...
Job description
MAIN JOB RESPONSIBILITIES / COMPETENCIES: 1. Develop and execute plans to expand QC laboratory capabilities for microbiology, to include, but not limited to: a. identification and purchase of necessary equipment b. writing, coordinating and performance of equipment qualifications c. development and/or revision of new or improved microbiological methodologies d. writing, coordinating and performance of validation of microbiological methodologies e. development of standard operating procedures f. establishment of database for test results g. management of microbiology laboratory 2. Perform routine microbiological testing: a. product and water system bioburden b. biological indicator (BI) testing for sterility c. BI population verification d. product sterility e. material and product cytotoxicity f. endotoxin testing g. environment monitoring 3. Ensure that all the samples are tested according to specified methods and devise a system to ensure full traceability of the samples. 4. Review, analyze and interpret data from samples. 5. Subject Matter Expert for microbiology. 6. Lead and support research and development and method development efforts. 7. Develop or assist in developing expe...