Keith Everiss Email & Phone Number

Sunnyvale, California, United States

Sunnyvale, California, United States

San Francisco Bay Area

San Francisco Bay Area

Managed the QC responsibilities for all Affymetrix Microarray Reagent product lines and the USB branded Molecular Biology and Biochemical products.Supervised the quality control team in the undertaking and ISO documentation of appropriate analytical and functional testing on incoming raw materials, intermediates and finished products to ensure they met required specifications.Designed and implemented processes and testing to support the manufacture, expiration dating and qualification of IVD products. Ensured all processes were controlled and in compliance with defined quality standards.Represented Quality Control in FDA and Customer Audits.Defined, measured, monitored and analyzed key performance indicators.Experienced with the design and execution of Validations, CAPA’s, NCMR’s and Deviations, Risk Assessments, Out of Specification Test Result Investigations and Root Cause Investigations.Applied Six Sigma Black Belt training and Lean Tools to reduce product lead times, increase capacity, reduce E&O and improve COGS through cross-functional process improvements.Represented Operations on product development teams as part of the Advanced Product Lifecycle process. Provided technical and regulatory guidance and devised risk mitigation strategies based on product/raw material critical attributes to achieve product realization.Coordinated with manufacturing, purchasing, and commercial operations to ensure that inventory of materials were kept in line with commercial needs.Worked as a member of the Global Product Support Team to understand, investigate and alleviate customer concerns and product performance issues.Managed the successful transfer of QC operations from California to Ohio and the transition of QC from ISO9001:2000 to the ISO13485 Quality System.

Managed the QC and Radiation Safety Officer responsibilities for all USB Molecular Biology and Biochemical products.Supervised the quality control team in the undertaking and ISO documentation of appropriate analytical and functional testing on incoming raw materials, intermediates and finished products to ensure they met required specifications. Oversaw the development and documentation of appropriate analytical tests and departmental procedures to ensure all processes are controlled and in compliance with defined quality standards including ISO9000:2001. Coordinated with manufacturing, purchasing, and commercial operations to ensure that inventory of materials were kept in line with commercial needs.Directly advised customers on technical, regulatory and quality-related product issues. Served as a member of the Product Roadmap team.Ensured that all customer inquiries were adequately resolved through direct customer communications (customer site visits, teleconferences, documentation).

Assisted the Quality Control Department in developing and implementing molecular biology assay methods and testing procedures.

Devised and executed research plans to characterize Epidermal Growth Factor variant mediated glial cell transformation and pathogenesis of human brain tumors.Managed the Kung laboratory including proper operation of the general laboratory, management of grants and the laboratory's safety program, secured funding for research by writing and editing grant applications and initiated measures to prevent budget deficits. Trained students and neurosurgery residents in laboratory techniques and research design.

Biological Basis of Disease I laboratory and small group instructor. Instructed first year medical students in bacteriological laboratory techniques and selected topics in molecular biology and microbiology.Molecular Biology, Health Career Enhancement Program for Minorities. Taught underrepresented undergraduate minority students molecular biology as part of a summer program to prepare them for medical or research careers.Biology 210 Molecular Cell Biology, Small Group Instructor. Taught undergraduate students molecular biology in the recitation section of this semester long course. Lectures were designed to clarify and augment main lecture material. Prepared lectures, assessed students performance using quizzes and evaluations of homework and class participation.

Doctorate, Microbiology And Molecular Biology

Researched the pathogenesis of Vibrio cholerae using, microbiological, biophysical, and molecular biology techniques Served three years.

Bs, Microbiology

Activities and Societies: President Sigma Alpha Epsilon fraternity, Ohio Kappa chapter Member, University Honors Program