Microbiologist/Sterilization Tech Needed in Irwindale

Kelly Scientific has an excellent opportunity for a Sterilization Microbiologist position located in Irwindale, CA. This is a biomedical company that produces diagnostic and therapeutic catheters, and 3D cardio mapping and navigation.SUMMARY: Support Microbiology Lab activities, including environmental monitoring and product testing functions as well as sterility validation programs. Involved in the release of sterile finished devices for commercial distribution based on review and approval of pertinent test results (i.e., sterilization cycle records, contract lab reports, microbiology lab reports, final inspection, etc.).ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.' Testing support for environmental monitoring program for clean rooms, purified water system and clean compressed air system.' Support bioburden and biocompatibility testing program. Review of test results generated by the internal microbiology lab, and external laboratory services.' Support in maintenance of specifications and SOP's that pertain to microbiological testing of product, microbiological testing of clean rooms, purified water and clean compressed air. ' Support scheduling and data review of annual validations of contract sterilizers.' Support in generating and providing corrective action recommendations for all non-conformances related to the microbiology lab, sterility assurance and environmental monitoring.' Provide recommendations, support and possibly lead process validations that pertain to sterilization, environmental process control, purified water system, and clean compressed air.' Provide recommendations and support on equipment or test method validations for equipment used within the microbiology lab or by the microbiology team.' Work with Facilities Engineering and support required testing after maintenance on the following validated facility systems: Clean rooms, Purified Water, and Clean Compressed air.' Provide support for microbiology issues.' Other miscellaneous duties as needed to support the business.QUALIFICATION AND REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.EDUCATION and/or EXPERIENCE: BS Degree in a life or physical science, 2-5 years of experience with good knowledge of company operations, quality standards and GMP regulations. ' Ability to use knowledge of regulatory, technical, and business requirements to perform microbiology work.' Ability to apply time/project management skills in areas of responsibility.' Knowledge of Quality and operations systems and processes, including GMP and QSR requirements for medical devices.' Demonstrated problem solving skills.' Famliarity of Six Sigma and Process Excellence tools and methodologies. ' Demonstrated verbal and written communication skills, and ability to effectively communicate with internal and external personnel. Learn more about company