Description
* University of California Santa Barbara, CA. on the Nomination of the faculty: * Graduated Dean's Honors Fall 1994, Bachelor's Degree majoring in Biochemistry-Molecular Biology * American Society for Quality: (recertifications pending as required) o "ASQ" Certified Quality Engineer 5/23/2010: Certification No. 55743 2013 o "ASQ" Certified Quality Auditor 6/5/2010: Certification No. 40845 2013 o Aseptic Processes/Sterilization, Primary Tertiary secondary primary packaging Microbiological Testing, vs Final Package/meets label claims. * Team Building, Scientific Methods o Contributed timely and effective solutions partnering, verbal/report/staff meetings/ etc. with managers, lab vendors, equipment calibration/maintenance/reliability, reduce redundancy, adherence to all and/or critical processing areas that require: * Microbiology based controls (ie. Staphylococcus aureus), Robust lab/personnel safety, controls, monitoring: essential, ID, lab safety rules critical, Risk Management, HACCP, differential media challenge, etc. o Microbiology and Sterilization: * Fo, D & z- value definitions, F-value, Lethal rate, determination of min required Fo: Autoclave cycle validations. * Overkill approach, combination approach, bioburden approach. o Autoclave Sterilization Design, control systems: * Gravity Displacement Cycles * Pre-vacuum, Pulsing, Steam-Air and Steam-Water-Air Cycles * Immersion Cycles * Drying Cycles, Etc. * Apply strict controls of Class III and or Class II and 1 - aseptic processing facilities, demonstrate integrity of personnel gowning, controls of incoming raw materials, microbiological testing/identification, and additional monitoring if applicable. * Adhere to quality policies, ie., regulatory requirements, strict adherence to Class I, II and III cleanroom/gowning procedures. * Co-develop new and/or supportive test methods, adding initiatives based upon predetermined management objectives. p 2 * Strive enhance organizational performance goals, conducting spot and formal internal audits: ensuring integrity of product through lifecycle to final labeling claims/primary, tertiary and finished goods integrity packaging. * Work with engineering teams, technical drawings, audit roles and responsibilities, etc. as directed.
Education
SCHOOL | MAJOR | YEAR | DEGREE |
---|---|---|---|
University of California | Biochemistry-Molecular Biology | 1994 | Bachelor Degree |
University of California Santa Barbara | Undergrad Dean's | 1984 | Bachelor Degree |