Senior Quality Assurance Lab Technician
CurrentTest raw materials, in-process, and finished osteobiologic product samples per USP/compendial methods and industry standard procedures such as X-Ray Diffraction, Endotoxicity (LAL), Cytotoxicity, and BioAssays.Maintenance of cell culture including cell growth and cell differentiation of Human Endothelial Cells specifically osteogenic stem cells. Have maintained and tested over 1000+ individual osteogenic samples.Perform routine laboratory maintenance tasks including organization and cleaning of work areas, checking for expired reagents and standards, disposal of product samples, chemicals and hazardous waste, and maintenance of lab inventory. Have operated and maintained laboratory equipment and computerized instruments such as HPLC, plate readers and microscopes, etc.Work closely with Manufacturing and Research and Development Departments to ensure that top quality products are produced within industry guildlines, new products are designed and throughly tested prior to release, and resolve issues found within the process through a CAPA process.Perform Environmental Monitoring of Clean Rooms ISO Levels 5 and 7. Also, conduct Bioburden testing including pH and Conductivity on all de-ionized Water systems within facility.Calibration, maintenance and operation of lab instrumentation, including: balances, pipettes, pH meters, ovens, and temperature chart recorder. Conduct Oven Surveys for necessary ovens within facility critical to product manufacture.Perform necessary validations for equipment, including software validations, critical to the manufacturing or quality testing process within the facility. Documentation of laboratory work using laboratory worksheets/notebooks that must be detailed, accurate and meet cGMP requirements.