Quality Lab Associate II - Endotoxin

Conduct microbiological analysis on raw materials, solution, and water samples following approved Standard Operating Procedures in an accurate and timely manner. Prepare samples and perform endotoxin testing on raw materials, solution, and water for bioburden. Perform particulate matter testing on solution. Perform daily pH meter, balance, and pipette verification. Perform daily Honeywell automated temperature checks and manual temperature monitoring. Perform peptidoglycan and gel clot testing as needed. Manage reagent inventory. Generate monthly trend reports. Calibration of micro-pipettes, analytical balance, water bath, dry heat bath, depyrogenation ovens, light obscuration particle counters and spectrophotometer. Responsible for daily lab upkeep including cleaning, glassware washing and depyrogenation, supply replenishment, syringe and endotoxin prep. Assist in method validation and protocol testing as needed. Sustain a clean and safe work environment utilizing 6S principles. Operate laboratory instrumentation and equipment such as laminar flow hoods, micro-pipettors, pH meters, analytical balances, and instruments used to perform particulate matter and endotoxin testing. Write and revise Standard Operating Procedures and review job-related technical documents. Perform laboratory and manufacturing audits as required. Train others to perform microbiological testing/tasks. Serve as mentor to Quality Lab Associate I (QLA I) positions. Serve as a back-up to Quality Lab Associate III (QLA III) in their absence. Write exceptions, nonconformance reports (NCRs) and CAPAs as needed utilizing TrackWise.