Supervisor, Quality Lab - Endotoxin

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. Administrator for Honeywell Automated Temperature Monitoring System. Perform peptidoglycan and gel clot testing as needed. Review calibration and daily lab check reports and approve testing. Generate monthly trend reports. Perform limit recalculations for trending purposes. Conduct investigations for out of limit results. Sterility testing for LAL. Document Subject Matter Expert. Act as a liaison between Endotoxin lab and Operations for batch release test scheduling to ensure customer commitments are met. 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. 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, revise, and approve Standard Operating Procedures and review job-related technical documents. Participate and/or support internal/external, and regulatory audits as needed. Write exceptions, nonconformance reports (NCRs) and CAPAs as needed utilizing TrackWise. Train others on systems, equipment, procedures as needed. Serve as mentor to other Quality Laboratory positions. Assist in the development and execution of department initiatives and KPI’s and effectively achieve team goals and expectations. Assist in the development planning of direct reports. Generate and execute protocols and method validations as needed. Assist Investigators as needed with microbial out of limits investigations. Act as a delegate for Quality Manager in their absence. Ensure compliance with all applicable procedures/practices to include global and local SOP’s safety, USP, ISO, cGMP, and applicable regulations.