Amanda Kite Email & Phone Number

As a QA auditor, I have experience with auditing protocols, deviations, SOP’s, CoA’s, in-life critical phase audits; raw data and final reports of basic complexity and of routine study design conducted at the Testing Facility and outside of the testing facility, to assure accuracy and compliance with Good Laboratory Practice (GLP), Standard Operating Procedures (SOP) per FDA, EPA, and/or OECD guidelines. Maintain written and signed records of auditing activities. Using discretion and independent judgment in providing recommended corrective actions to management and study directors. Additional responsibilities include: - performing site Quality System audits (process/facility/equipment/validation) and review of corresponding regulatory documentation to ensure compliance- assist with qualification audits of subcontractors- assist with sponsor/agency site audits; - participate in other QA projects.As a Research Biologist, I specialized in the Developmental and Reproductive Toxicology studies (DART) but was cross trained in General Toxicology studies as well. I served as a lead/primary technician for multiple basic and complex in-life studies simultaneously. Collected and recorded data with minimal supervision in the performance of studies. Responsible for handling and restraining animals, clinical observations, sample collection, monitoring food consumption, animal husbandry, and performing accurate data collection and reporting. Administer test substances by various basic and intermediate methods. Serve as a mentor to less experienced staff.Dosing skills include oral gavage dosing (rodents/rabbits/dogs), Intravenous dosing (rodents/rabbits), subcutaneous dosing (rodents/rabbits/dogs) and administration of dietary admixes. Phlebotomies for rodents (via jugular, tail vein or retro orbital sinus) and for rabbits (via ear artery or vein by straight needle and syringe), euthanasia of rodents/rabbits (CO2 inhalation/ sodium pentobarbital or isoflurane inhalation), collection of rodent vaginal smears to determine pregnancy or stage of estrous, behavioral testing (Biel maze, Functional Observation Battery (FOB's), Motor Activity, Startle), vaginal perforation, balanopreputial separation, pinnae detachment, animal placement for randomizations.

Listed skills include Science, Biology, Animal Models, In Vivo, and 26 others.