Laboratory Technician

hace 3 semanas

Tijuana, México Avanos A tiempo completo

**_Laboratory Technician_****Primary Responsibilities**- Execute environmental monitoring sampling (viable and non-viable particles, surface monitoring, air and water sampling) according to established procedures.- Perform endotoxin testing on finished products, subassemblies and raw materials using validated methods (LAL gel-clot, turbidimetric or chromogenic).- Prepare media, reagents and test materials in accordance with laboratory work instructions.- Record all test results clearly and accurately in laboratory notebooks, forms and/or electronic systems.- Ensure traceability of samples and materials used during the testing process.- Coordinate equipment calibration and routine maintenance according to scheduled intervals.- Assist with method validation studies and trend analysis of environmental and endotoxin results.- Support investigations related to deviations, out-of-specification (OOS) results or non-conformances.- Comply with Good Laboratory Practices (GLP) and all applicable procedures within the Quality Management System (FDA 820 / ISO-13485).- Participate in internal and external audits by providing records and technical information when required.**Requirements**:- Technical degree or associate degree in Laboratory Technology, Microbiology, Biotechnology, Chemistry or related field.- Preferable previous experience in microbiological testing, environmental monitoring or endotoxin testing (preferably within the medical device industry).- Preferable knowledge of regulatory standards: ISO 13485 and FDA 21 CFR Part 820.- Ability to follow standard operating procedures and interpret technical documents.- Knowledge of MS Office tools (Excel, Word and lab software).

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