crystal kortz
senior project manager
About
Leads by encouraging direct reports to be engaged, think strategically and analyze root cause, problem solving to make risk based decisions under a high pressure/fast paced environment. I am eager to learn technical aspects of processes to drive quality, efficiency, accountability and continuous improvement.
united states
newark
pharmaceuticals
quality assurance, gmp, validation, change control, continuous improvement, deviation management, 21 cfr part 11, 5s, cgmp practices, cleaning validation, environmental monitoring, sap, inventory control, lean thinking, trackwise, pharmaceutical microbiology, quality risk management, incoming quality, solid oral dosage manufacturing, pharmaceutical industry, sop, capa, cross functional team leadership, process improvement, fda, quality system, u.s. food and drug administration, business process improvement
Experience
senior project manager
astrazeneca
microbiology laboratory supervisor
terumo bct
Led the Microbiology laboratory performing testing for the manufacture of medical devices (environmental monitoring, testing of purified water, endotoxins and bioburden). Reviewed and approved test results. Primary responsibility for the personnel and equipment within the laboratory. Maintained effective employee relations and compliance to cGMP, other regulatory requirements, as well as Safety, Health, and Environmental obligations and company standards. Implementation of LEAN practices and led 5S initiatives for plans of laboratory renovations.
Education
university of delaware
animal science
Animal Science Major with a concentration in Prevetinary Medicine Earned a B.S. in Agricultural Sciences
wilmington university
In process of working on a MBA in Marketing (75% completed)
crystal kortz's Contact Information
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