Kenneth Daus Email & Phone Number

PROFILECompetent Quality Assurance Specialist with over 13 years quality and regulatory experience in the biotech and drug listing field who can work independently or in a team setting to accomplish the company's goalsHelped audit 1681 studies for quality and regulatory compliance while maintaining a 97% on time delivery rate for the year. For 42 out of 52 weeks a 100% on time delivery rate was achieved.Contributed to the development and implementation of new practices in various product lot release groups to achieve same day/ next day goals. On average the studies were audited and sent to the client 7 to 10 days faster than standard turn-around time.Contributed to the development of a process for auditing and transferring of the samples, data and reports between multiple laboratories and quality assurance for novel assay methods and processes. Robust familiarity with the Food and Drug Administration's 21 Code of Federal Regulations parts 210, 211, 610 and 207, Points to Consider in the Characterization of Cell Lines used to Produce Biologics (1993), European Pharmacopeia, Good Manufacturing Practices and Good Laboratory Practices.Specialties: forms, glp, gmp, government, interpretation, personnel, protocols, quality, quality control, reports, scientific, technical training, training,

Listed skills include Gmp, Fda, Sop, Biotechnology, and 14 others.

• 

  State University Of New York At Oswego

  Biology