Rola Tannous

Background

About Rola Tannous

Analyze antibiotic potency of finished products by means of cylinder plate/turbidimetric assay methods to confirm product consistency-Environmental Monitoring (EM) of classified areas; cleanrooms ISO 8, ISO 7; including viable and particle monitoring-Aseptic gowning-Monitoring of Purified Water systems-In Process testing on finished products-Determine amount of microbes in finished products through Microbial Limits Testing (MLT) to ensure industry/FDA standards are met-Run daily Bio-Burden testing for Purified Water (PW) and Water For Injectable (WFI) to determine number of viable microorganisms-Determine Endotoxin quantitation of WFI and finished products by means of LAL Gel-Clot method to guarantee absence of endotoxins-Sterilize laboratory equipment, instruments, and any in-house media to remove any and all microorganisms for sterilized testing requirements-Microbial Identification by means of VITEK systems-Execute quality control tests including sterility testing and pH adjustment of prepared and in-house media, commercially prepared products, and parental products-Maintain/calibrate pH meters, analytical balances, autoclaves, zone readers, water baths, and other lab equipment-Prepare/maintain organisms from frozen stock USP standards weekly to ensure fresh samples are available for QC and R&D testing-Adhere to and help enforce all health, safety, and environmental regulations relative to assigned analytical work; maintain and assist others in maintaining a clean and safe work environment-Ensure all regulatory procedures pertaining to sample testing are followed correctly-Assisting in day-to-day operations of the testing and release of samples and raw material-Train new hires