Kenyon Stephan Email & Phone Number

Durham, North Carolina, United States

Durham, North Carolina, United States

- Host Audit inspections by FDA, CLIA, PPTA, and Internal Compliance. - Maintains thorough understanding and ensures compliance with state and federal regulations, U.S. Food and Drug Administration (FDA) approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), and Current Good Manufacturing Practice (cGMP).- Experience with Deviation Tracking System and CAPAs to identify and investigate product and quality problems, and take appropriate and effective Corrective and Preventative Action to prevent their recurrence. - Responsible for maintaining and meeting monthly and quarterly Quality Key Performance Indicator (KPI) goals- Provide technical guidance to the Operations team to assure employee safety, donor safety, and product quality. - Review of 2000+ plasma donations for approval and release for bi-weekly product shipment.- Review of incoming donation supplies for sterility and inventory release. - Daily review of donor record files, deviations, root cause investigations, incident reports, and technical documents related to quality assurance programs.

- Train new employees on all procedures, policies and responsibilities of a Quality Associate and Donor Center Technician. Develop trainees to become high performers to grow into leadership positions. - Ensure new employees follow a timely training schedule to uphold compliance and perform their duties to perfection while learning to be quality oriented.

- Perform venipuncture to ensure safe and accurate plasmapheresis.- Monitor plasma donors during and after plasmapheresis procedure to ensure health, safety, and comfort as well as quality of product.

Indianapolis, Indiana Area

- Selection of suitable plasmapheresis donors through the use of FDA approved Standard Operating Procedures, OSHA, CLIA, and cGMP to ensure a quality product. - Performing physical examinations and evaluations of medical history, medications, and overall donor health including lung and heart sounds, musculoskeletal function, cognitive function, and immune health. - Screening donors for suitability by measuring and recording blood pressure, pulse, temperature, hematocrit and plasma protein levels; and reviewing medical history questions.

Purdue University

Controlled daily operations of tennis courts and Pro Shop by scheduling and organizing courts; registering players for programs, lessons and tournaments; membership services; taking payments; selling merchandise; inventory control; and stringing racquets.

Purdue University

Conducted individual research project to determine most efficient method for measurement and analysis of corn starch content. Tested and quantified amylose content amount of corn samples by using amylose/amylopectin assay procedure, and compiled the data for outside hiring companies.

Bachelor Of Science (B.S.), Major: Biology/Biological Sciences | Minor: Psychology

Activities and Societies: Purdue University Dance Marathon

Emt-B Certification

Education record

Activities and Societies: Varsity Tennis (Team Captain)