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).