Scientist I

Location: Irvine, CA Shift: Sunday - Thursday OR Tuesday - Saturday The Scientist Level 1 will report directly to the Laboratory Lead/Manager and after training will perform routine testing in compliance with laboratory test methods and procedures to support the manufacturing and timely delivery of product to customers (80 to 100%). As a trainee, the Scientist 1 must have the ability to assimilate and apply information rapidly. The Scientist I will receive general instructions about required tasks and results expected. Work will be well defined and is reviewed for accuracy upon completion. The Scientist 1 is expected to apply standard practices and techniques in specific situations and to recognize discrepancies in results and follow operations through a series of detailed steps and processes. Additionally, the Scientist Level 1 has accountability and ownership to maintain laboratory instruments in their qualified state. Responsibilities: Performing with competence, upon training, routine testing following laboratory test methods and procedures. Developing a competence, upon training, in the use of laboratory instruments and equipment. Performing daily calibrations/verifications and routine maintenance of laboratory instrumentation and equipment according to current SOPs. Working in compliance with current GMPs with regard to documenting, testing and maintaining accurate laboratory notebooks and data sheets. Raw material, In-process and finished goods testing when thorough training has been completed. Initiation and participation in laboratory investigations of non-conforming laboratory test results. Collecting and preparing laboratory records for evaluation following good documentation practices. Ensuring personal compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance. Qualifications: Required Bachelor's Degree in a scientific discipline. such as Microbiology, Biology, or a closely related field 0-2 years in laboratory or related environment Strong understanding of compliance with applicable laboratory and safety procedure Must be self-driven, have strong critical thinking and problem-solving skills, and capable of working independently or in a team. Must possess effective oral and written communication skills as well as demonstrate the ability to effectively function in a cross-functional team environment Preferred Knowledge of sterilization, disinfection and cleaning technologies for reprocessing of medical devices is strongly preferred Professional experience in a GxP-regulated industry and understanding of QSR, FDA, and ISO guidelines Working experience with sterilants and disinfectants Working knowledge of designs and features of medical devices