RONALD J.

BURKEY
Tukwila, WA 98168 509-942-4502 krcron@gmail.com

SUMMARY PROFILE Detail-oriented Quality Assurance Professional with 15+ years of diversified and challenging positions in a research setting. Experience includes implementing and maintaining compliance for a variety of regulations and providing QA oversight in an Biotechnology Contract Research Laboratory. Working knowledge of GLPs and GDPs, trained in cGMPs, GCPs, FDA 21 CFR part 820 and ICH Guidelines. Recognized for excellent interpersonal skills and the ability to be comfortable and capable interfacing with both internal clients and external auditors along with technical experience and a Masters of Science. Areas of expertise include Supplier and Internal Audits & Surveillances Vendor Audits / Qualification Training Development, Delivery, Tracking Procedure Writing, Editing and Reviewing Client & Federal Audit Hosting Document Control Electronic and Paper Computer and Spreadsheet Validation Instrument Qualification, Acceptance, Validation Staff Supervision Corrective and Preventive Action (CAPA) Data & Report Audits & Reviews

PROFESSIONAL EXPERIENCE BATTELLE TOXICOLOGY NORTHWEST, Richland, WA 1997 2010 Preclinical Inhalation Toxicology Good Laboratory Practices Contract Research Organization with clients from Pharmaceutical, National Toxicology Program and other industries. Researcher 2006 2010 Provided leadership for teams of up to 11 members running the day to day exposure operations of a GLP CRO supporting US and international clients on an ongoing basis. Reduced Quality Assurance audit findings by 35% within 9 months of transferring to the Engineering group by conducting training, revamping procedures and conducting internal assessments. Worked with study staff ensuring laboratory events occurred as scheduled and within budget. Wrote calibration and maintenance procedures for measuring and test equipment. Liaised and assisted Health and Safety Officer with tasks meeting regulatory and health and safety requirements for the facility and hazardous materials and waste. Validated Excel spreadsheet in accordance to Standard Operating Procedures (SOPs). Validated exposure and computer systems for compliance with regulations and 21 CFR part 11. Conducted training of staff to project requirements, procedures and for process improvements. Reviewed data for compliance with study protocol, SOPs and regulations. Wrote and revised SOPs for studies, equipment and facility operations. Reviewed study reports against study data for accuracy. Quality Assurance Officer 1997 2006 Became an informal liaison between the Quality Assurance Unit and the Technical groups resulting in increased communication and a better understanding of the purpose of the regulations and clients requirements. Personally migrated Master Schedule from paper records to MS Excel database. Implemented a supplier evaluation program. Hosted external surveillances and audits by government and client auditors. Evaluated computer, equipment and system validations for compliance with facility procedures and regulations (GLP and 21 CFR part 11). Assisted project managers to establish procedures to assure GLP compliance.

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Evaluated the compliance of studies to FDA, EPA and OECD GLP regulations, study protocols and SOPs by performing facility (analytical, engineering, and animal labs) and project specific surveillances. Reported findings and recommended corrective action to management and followed up to track and document corrective action taken. Conducted data (paper and electronic) and report audits, reported findings to management. Wrote and maintained SOPs for the Quality Assurance Unit and facility operations. Archived study data, protocols and reports at study completion in controlled facility files. Reviewed sampling and analysis procedures and activities. Generated and delivered training for staff and management on regulatory, procedural and Health and Safety requirements. Maintained computerized files of the Quality Assurance Unit including Master Schedule, inspection scheduling, planning and reporting. Reviewed proposals, SOPs and study protocols for completeness, accuracy, and compliance with current regulations and statements of work. Prepared cost estimates for proposals. BATTELLE, Pacific Northwest National Laboratory, Richland, WA 1993 1995

Quality Engineer Wrote project-specific Quality Assurance plans to client requirements (NQA-1, 10 CFR 830). Trained as NQA-1 Lead Auditor. Participated in audits of subcontractors facilities. Performed internal audits and surveillances onsite and at remote field project locations. Provided primary support to the Waste Management / RCRA facility to insure compliance to EPA, DOT, and PNNL requirements. Conducted assessments of packaging and shipping hazardous and radioactive wastes to RCRA and DOT regulations. Inspected onsite and offsite treatment, storage, disposal, and transportation of hazardous and radioactive wastes. Prepared and reviewed field and laboratory procedures. Conducted assessments of ground water, surface water and soil sampling activities to various procedures including EPA protocols, and assessments of packaging and shipping hazardous and radioactive wastes to RCRA and DOT regulations Conducted data audits of reports. Assisted in the establishment a QAU for the conduct of EPA GLP studies, this included writing SOPs, maintaining files, conducting inspections and data audits. Interfaced with line management, project management, scientists, technicians, and external clients.

EDUCATION MS, Environmental Science, Washington State University, Richland, WA BS, Geology, California Lutheran University, Thousand Oaks, CA

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ADDITIONAL TRAINING AND EXPERIENCE Essentials of Project Management, Villanova University, web based training Society of Quality Assurance, five-day annual meeting / training, Washington, DC 2003 & San Diego 2001 Computer Validation in the FDA Regulated Environment Analytical Chemistry for the QA Professional, Society of Quality Assurance Auditing Methods for Lead Auditors DOE QA Requirements and NQA-1 Environmental Quality Assurance Surveillance Methodology CPR / First Aid Certified current Member of Battelle Toxicology Northwest Health & Safety Committee Court Appointed Special Advocate / Guardian ad Litem (CASA/GAL), 2002 present Court appointed representative for abused and neglected children. Interact with judges, attorneys, parents, social workers and children as the childs advocate and representative.