Curriculum Vitae Rhonda L. Ezell Permanent Address: 4541 Hwy 101 Rogersville, AL (256) or (256) (cell)

Transcription

1 Curriculum Vitae Rhonda L. Ezell Permanent Address: 4541 Hwy 101 Rogersville, AL (256) or (256) (cell) OBJECTIVE A position that will utilize my knowledge of quality, food safety and expertise in microbiology and provide rewarding challenges along with advancement opportunities EDUCATION Currently working on PhD in Food Science (emphasis in Food Microbiology), Alabama Agricultural and Mechanical University, Huntsville, Alabama (expected graduation date May 2015) Master of Science, Biology/Microbiology, University of Alabama-Huntsville, Huntsville, Alabama, 1995 Bachelor of Science, Biology Microbiology emphasis, University of North Alabama, Florence, Alabama, 1987 PROFESSIONAL EXPERIENCE Qualitest Pharmaceuticals Site Director of Quality and Compliance Liquids Facility September 2012-Present Reponsible for overall Quality Control and Quality Assurance for the Liquids Facility. Ensure regulatory compliance. Manage a team of seven managers and over 50 quality employees. Director of Quality Control and Microbiology November 2011-September 2012 Director of quality control laboratories in the Liquids facility. Manage a team of two managers, five supervisors, and about 50 analysts. Responsible for all testing analyses for Liquids facility products. Qualitest Pharmaceuticals October 2006-November 2011 Manager of Microbiology Function as the manager for a team of two microbiology supervisors, eight full-time microbiologists and one technician Conduct investigations into product failures, and microbiological issues related to pharmaceutical manufacturing Assure strict adherence to compendial methods, FDA regulations and Good Laboratory Practices Serve as a member of the Plant Safety Committee to develop procedures to insure compliance to OSHA, EPA and state regulatory agencies Perform investigations for out-of-trend analyses, out-of-specification analyses and investigations into microbiological issues arising from instrumentation, methods, or analyst technique Maintain concise documentation on all product testing and corrective actions Issue reports to plant managers on product testing, investigations, and raw material analyses Ensure timely analyses of final pharmaceutical products, raw materials and process water to meet customer orders

2 Experienced in FDA inspections and responses to audit findings; experienced in upgrading a noncompliant microbiology laboratory to full compliance after regulatory issues Brown-Forman Corporation April 2005-October 2006 Jack Daniel Distillery Microbiologist/ Whiskey Technical Resource Served as the Whiskey Technical Resource for all matters pertaining to microbiology in the distillery Served as a member of the Research and Development Team to recommend and implement changes to the process to improve efficiency and ensure product quality Conducted pilot fermentation studies to improve fermentations and product yields Maintained all cultures in the microbiology laboratory using several culture techniques Functioned as a resource for employee health issues relating to environmental microbiology Functioned as a resource for regulatory issues (FDA Bioterrorism, EPA etc.) Conducted extensive water testing as needed to monitor water systems Served as the technical resource for FDA, state and local health department inspections and other audits My position as the Whiskey Technical Resource included research and development functions and process improvement functions. The major responsibilities were trouble-shooting and special testing. I was part of the Corporate Team to improve distilleries across the company by developing and implementing procedures and processes particularly those relating to microbiology. Cargill Inc., Decatur, Alabama Quality Assurance Team Coordinator/ Senior Microbiologist Managed nine chemists in the Quality Assurance Laboratory Managed activities involving final product quality assurance and raw materials quality assurance Developed, implemented and managed the Sanitation Program for the facility Developed microbiological testing protocols for the plant Developed and implemented a Fume Hood Program for all fume hoods in the plant Managed and directed the plant s pest control program Developed Legionella testing program for the plant s cooling tower system Managed and directed HACCP Program and GMP Program Met with fellow microbiologists across the country to update programs and ensure uniformity of programs across the division Conducted audits for GMP, GLP, FDA, HACCP, Food Safety and other internal programs, suggested improvements and conducted follow-ups for corrections Served as a member of the Customer Complaint Resolution Team Served as the representative for the United States microbiologists at the world-wide meeting of Cargill Microbiologists My position as Quality Assurance Team Coordinator/ Senior Microbiologist at Cargill included testing product quality to ensure that all product shipments met microbiological specifications. This included monitoring viable counts, direct microscopic examinations, in-process surveys of tanks and process points, tank inspections, plate assays and monitoring of raw materials. This position also involved special projects and special testing in areas other than microbiology. Other major responsibilities included in-house bloodborne pathogen training for all plant employees, compilation and update of the BBP Program for OSHA compliance, industrial hygiene projects such as implementing a Fume Hood Monitoring Program and fume hood testing, working as a member of the Emergency Response Team and as a First Responder and compilation and implementation of a HACCP Program for our plant. I also developed and implemented the Standard Operating Procedures for the Microbiology

3 Laboratory to conform to the Good Laboratory Practices Standards. Specialized tests for the wet milling process were also performed including starch testing, corn and corn viability testing and other procedures. State of Alabama Department of Forensic Sciences Laboratory Technician Drug Chemistry and Serology Drug Chemistry-My responsibilities included drug extraction, instrumental analyses of controlled substances, operation of an Infrared Spectrophotometer, Gas/Chromatograph/Mass Spectrum Analyzer and Polarizing Microscope. I also produced computer spread sheets, ordered supplies and wrote drug descriptions from evidence. Serology- My responsibilities in this section included evidence preparations, blood typing, presumptive blood tests, microscopic examination of slides, special testing of saliva, blood, semen and other body fluids, laboratory maintenance and reagent preparation. Work at another regional laboratory included fingerprinting, evidence logging, drug chemistry and writing cases. Auburn University- During the Fall Quarter of 1988, I was employed as a Graduate Teaching Assistant for the Department of Biology teaching undergraduate laboratories, grading papers and conducting laboratory experiments for class. PUBLICATION Authored the chapter, Determination of Objectionable Organisms in Non-Sterile Pharmaceutical Products A Science-Based Risk Assessment Approach in the book, Microbial Indentification: The Keys to a Successful Program By Mary Griffin and Dona Reber, Editors. Published by the Parenteral Drug Association (PDA), TEACHING EXPERIENCE Taught Agricultural Enzymes class at AAMU Taught undergraduate biology laboratories at Auburn University while working on graduate degree Taught Food Plant Sanitation, GMPs, FDA Regulations, Bioterrorism Security and HACCP Principles to plant personnel at Cargill Designed, implemented and taught the AED (Automated External Defibrillator) Program for all plant personnel at Cargill Taught Basic First Aid to plant personnel (Cargill, Jack Daniel Distillery and Qualitest Pharmaceuticals) Designed, implemented and taught Bloodborne Pathogen Program per OSHA Regulations Taught Jack Daniel s Fire Brigade Emergency Medical Training for brigade members Taught Business for the Junior Achievement Loaned Executive program to junior high students SPEAKING EXPERIENCE Institute of Validation Technology (IVT) Aseptic Processing Conference. Dublin, Ireland. November 15-16, Topics: Determination of Objectionable Microorganisms in Non-Sterile Pharmaceutical Products and Staying Abreast of FDA Guidelines for Microbiology. (By invitation) Institute of Validation Technology (IVT) Contamination Control Week. Boston, MA. June 25-27, Topic: Objectionable Organisms and Microbial Control. (By invitation) Pharmaceutical Microbiology Forum: Bioburden Contamination Control. Key Largo, FL. February 27-28, Topic: Objectionable Organisms and Microbial Control. (By invitation) 6 th Annual Global Conference on Pharmaceutical Microbiology-Parenteral Drug Association, Bethesda, MD. October 17-19, Topic: Determination of Objectionable Organisms in Non-sterile Pharmaceutical Products. (By invitation)

4 SMi, London, England. January Speaker for Pharmaceutical Microbiology Conference. Topic: A Risk-Based Approach for Determining Objectionable Microorganisms in Non-Sterile Pharmaceutical Products. (By invitation) The Pharmaceutical Microbiology Forum, Philadelphia, PA. June Speaker for Microbiological Data Deviations; Investigations and Risk Conference. Topic: Objectionable Organisms Assigning the Risk. (By invitation) The Pharmaceutical Microbiology Forum, Philadelphia, PA. June Speaker for Microbiological Data Deviations Conference. Topic: Determination of Objectionable Microorganisms. (By invitation) RELEVANT WORKING EXPERIENCE Currently completing series of training seminars on Bioterrorism including emergency response methods, agricultural response, integration of emergency agencies for appropriate response to disease outbreaks. Worked on Pilot Fermentations to isolate new yeast strains for production goals, special problem resolution and increased production yields Maintained Jack Daniel s proprietary cultures, scale-up cultures for production and maintained back-up cultures Familiar with Food and Drug Administration Bacteriological Analytical Manual procedures and the Compendium of Methods for the Microbiological Examination of Foods Performed surveys of food product for Listeria, Salmonella, coagulase positive Staphylococcus, coliforms, and Eschericia coli Experienced in the isolation and identification of microorganisms from various food sources including meats, milk, spices and other foods Familiar with membrane filtration methods, Most Probable Number procedures, direct count procedures and differential staining Served as a member of Cargill s Emergency Response Team, training includes 40-hour Specialist (HAZMAT) and 8-hour Incident Commander training. Refresher training each year Experienced in the isolation, culture and identification of molds (completed course at Purdue University) Knowledgeable in antibiotic disc assays, dilution techniques and positive control culture maintenance procedures Broad based knowledge in sanitation, pest control management, writing and implementing quality control procedures and Hazard Analysis of Critical Control Points in an industry setting Familiar with FDA regulations, OSHA regulations and state and local health department regulations. Tested companies cooling tower water systems for presence of Legionella Served as the Facilitator for the implementation of Socio-Technical Sytems (STS) for the Decatur plant. This involved coordinating activities with the other sister plants located in Hammond, Indiana and Dimmitt, Texas in order to streamline and increase production Served as a Team member for the Robust Team to solve problems relating to syrup, starch, feedstuffs and co-products from mill and identify and assess bottlenecks in the system Proficient in Excel, Powerpoint, Word, Access, Office and Lotus Notes computer programs. Capable of designing forms and templates Successfully completed 16-hour Bomb Threat Response Training Registered with the National Registry of Emergency Medical Technicians Volunteer for Rogersville Emergency Medical Services on ambulance and Elgin Volunteer Fire Department Conducted research, wrote and implemented a Bioterrorism Product Security Plan for the Decatur Cargill plant to address biosecurity needs Isolated and evaluated new yeast strains for use in the process to produce whiskey with desirable flavor characteristics and increased yields

5 Functioned as a member and instructor for the Jack Daniel s Fire Brigade Serve as a member of the Qualitest Pharmaceuticals Safety Committee Very skilled in writing Microbiological Investigations and determining root cause for microbiological excursions Developed internal pharmaceutical programs to ensure compliance to regulations including the development of a Risk Assessment Program for Potentially Objectionable Microorganisms; based on feedback from consultants, was recommended as a speaker for various microbiology conferences Developed internal Microbiology Professional Development program (MPD) to train the microbiology team in new developments, technical issues and training needs as defined by employee feedback and constant laboratory improvement Developed a Proficiency Program to assess training needs and skills of microbiology team Recent training includes: Interviewing Basics Management and Supervisory Training Root Cause Analysis QA Auditing Stepping Up I and II (management training) FDA Audit Readiness FMEA (Failure Mode Effects Analysis) TrackWise StarLIMS Conducting Environmental Excursion Investigations TASK FORCE PDA (Parenteral Drug Association) Task Force Currently serving as a member of the PDA Task Force to develop a PDA Technical Report for Global Framework for Assessing and Mitigating Risk from Objectionable Microorganisms. REFERENCES Avaliable upon request.