Environmental Monitoring (EM): Conduct routine microbiological monitoring of manufacturing areas, cleanrooms (Class 10k/100k), air quality, surfaces, and personnel gowning.
Sterility & Bioburden Testing: Perform bioburden testing on raw materials, in-process components, and finished medical devices before and after sterilization (EO/Gamma).
Bacterial Endotoxin Testing (BET): Execute LAL (Limulus Amebocyte Lysate) gel clot or kinetic testing to detect pyrogens on finished products.
Water System Analysis: Routinely sample and test the purified water system for microbial count, conductivity, and chemical parameters.
Media Preparation & Culture Maintenance: Handle media preparation, growth promotion testing,
sterilization validation of media, and maintain reference cultures safely.
Documentation & Compliance: Maintain accurate, real-time documentation of all tests, logbooks, and laboratory reports in compliance with ISO 13485, MDR, and GMP guidelines.
Out of Specification (OOS) Investigations: Identify, report, and investigate any microbial deviations or OOS results. Assist in implementing Corrective and Preventive Actions (CAPA).