Quality Control Assurance

SHARIF K. WALKER

**** ********** ****** ****, ** 27511 443-***-**** ***********@*****.***

EDUCATION

Bachelor of Science in General Agriculture Concentration: Animal Science

University of Maryland Eastern Shore, Princess Anne, MD December 2007

TECHNICAL COMPETENCIES

Working knowledge of Good Lab Practices(GLP), Hazard Analysis Critical Control Points (HACCP), International Organization for Standardization(ISO), Current Good Manufacturing Practices(cGMP), Standard Operation Procedures(SOP), ATP, Cell Culture, Sanitation Standard Operation Procedures(SSOP), USDA and FDA Regulations (21CFR)

Efficient in Microsoft- Word, Excel, & PowerPoint, Windows XP, Windows 7, Web Networks and SAP

Ability to utilize FDA databases: Operational and Administrative System for Import Support (OASIS); Field Accomplishment and Tracking Systems (FACTS); ORADSS (ORA Reporting Analysis, and Decision Support System), FURLS (FDA Unified Registration and Listing System)

PROFESSIONAL EXPERIENCE

Program Monitor/Consumer Safety November 2010 - Present

Oak Ridge Associated Univ. / FDA Center for Food Safety and Applied Nutrition- Office of Compliance- College Park, MD

Resolved questions, problems, and inquires generated from field personnel including conveying instructions regarding assignments, explanation of field assignments specifics and clarification of inspection procedures for food processing facilities.

Developed, summarized and revised new and updated Center Foods Compliance Programs, Collection Schedules and Field Assignments pertaining to Produce, Sprouts, and Mycotoxins.

Assured that the inspectional, analytical, legal and administrative operations required by the program are consistent with current FDA policy and fully integrates with other field operating procedures and instructions.

Obtained and prepared standard analyses of scientific data and prepared technical data findings and formulated recommendations based on background and understanding of policies, regulations, procedures of studies.

Prepared memoranda, briefings and other background material for upper management.

Improved and developed compliance and enforcement strategies to be included in Compliance programs, field assignments and policy manuals and formulate recommendations based on background and understanding of policies.

Reviewed and evaluated observations contained in inspection reports used to determine firms’ compliance with the regulatory requirements for foods and cosmetics.

Facilitated in the restructuring of CFSAN’s work plan, and advised on new technology related to new programs, laws and regulations to adhere to Food Safety Modernization Act (FSMA) mandates for field sampling.

Quality Control Associate Scientist II April 2009 - November 2010

Qiagen Sciences/ Quality Control Dept. - Gaithersburg, MD

Tested and received raw materials, aggregate samples, components and kits in compliance with QSR, ISO, OSH, IVDD, MDD regulations and relevant Standard Operation Procedures.

Executed product audits and batch record reviews for product manufacturing for labeling compliance and performed investigation on product deviations.

Reviewed and evaluated test methods and new automated methods of processing and analyzing.

Evaluated data for QC management analysis and advised supervisor of factors that may affect quality, accuracy and usefulness of data.

Maintained QC Reagent set and data trending of assigned product lines and independently scheduled QC testing.

Recognized problems, analyzed, offered sound technical solutions and Initiated Out of Specification (OOS) forms to document failure and investigations of product quality.

Independently performed essential lab functions while mentoring junior associates and providing input for process improvements and troubleshooting.

Assistant Immunologist I July 2008 - February 2009

Cel-Sci Corporation/ Bioassay - Baltimore, MD

Performed proliferative bioassays for QC drug potency including Analytical Method Validation for bioassays, and Statistical Analysis of data.

Drafted and Revised Standard Operating Procedure documents, Standard Specifications, Research & Development Protocols, and complying with company guidelines for document control.

Supervised workflow to assure specimen processing and laboratory testing is accomplished according to work schedule.

Completed routine laboratory maintenance which included preventative maintenance monitoring of equipment, requisition and inventory of all chemicals and disposables items/equipment, and participation in annual cycle counts of materials within laboratory facility.

Maintained documentation and laboratory records in accordance with Good Manufacturing Practices.

Issued and Tracked batch records, cell inventory, and drug product inventory.

Followed proper radioactive waste safety procedures.

Quality Assurance Crew Leader/Lead Inspector December 2007 - July 2008

Smithfield Processing Plant/ QA Department - Landover, MD

Supervised, Instructed and Trained new Quality Inspectors in the procedures and methods used to inspect, monitor, and audit processes and finished products.

Investigated consumer complaints of injury by product and provided corrective actions if claim was validated.

Collected samples and conducted field analyses involving weighing, oversight of packaging lines and production procedures to determine degree of consistency with GMP and efficacy of quality controls.

Prepare final reports, positions papers and other written documentation that supports investigative findings and recommendations for assigned programmatic activities.

Responded to questions and inquiries from FSIS Non-Compliance regarding facility food safety issues.

Conducted regulatory inspections and investigations of facilities with limited guidance to evaluate the complex manufacturing for GMP compliance.

Evaluated data generated by the Quality Department to determine trends and maximize process performance standards.

Validated, Developed, and Implemented HACCP and SSOP documentation to ensure that the requirements of the program were correct.

Generated and Maintained daily log of Pre and Post-operational microbial samples throughout the facility.

Assisted Production and Quality Supervisors in determining causes for process failures by supplying data and technical expertise.

Student Research Assistant, January 2007- December 2007

USDA, Agricultural Research Service, University of Maryland Eastern Shore - Princess Anne, MD

Conducted experiments to isolate and cultivate strains of Salmonella.

Translated data from experiments using protocol software for pathogen enumeration.

Collected data for computer models to forecast behavior of Salmonella in chicken.

Performed media and food sample preparation for weekly experiments.

Supervised and conducted daily biohazard waste removal and general lab maintenance.

SEMINARS & TRAINING

Joint Illinois Institute of Technology, Institute for Food Safety and Health/University of Wisconsin-Madison- Food Research Institute Mycotoxin Symposium, April 2012

Office of Regulatory Affairs- Field Food Committee (FFC) Annual Conference: Summary of FY10 Operations – 5-Year Evaluation of PPS 03: Micro Total Planned Hours vs. Total Hours Accomplished, March 2011

Radiation Safety Academy Certification, completion of 8hours of Basic Radiation Training, October 2008

Environmental Systems Research Institute Certification (ESRI), completion of 16 hours of Arc GIS software, November 2006

RECOGNITIONS

CFSAN/FDA 2011 Honor Awards: For Outstanding Contributions to the Development and Issuance of 10+ High Priority Assignments, June 2011

CFSAN/FDA 2012 Honor Awards: For developing and implementing a work plan business tool that assists in the planning efforts of the Agency’s annual domestic and import sampling performance plan. July 2012

Research and experiments to support Publication: Oscar, T.P. 2008 “Predictive Model for Survival and Growth of Salmonella Typhimurium DT104 on Chicken Skin during Temperature Abuse”. Journal of Food Protection 72(2):304-314.

Research and experiments to support Publication: Oscar, T.P. 2008 “Persistence of Salmonella Serotypes on Chicken Skin after Exposure to Kosher Salt and Rinsing”. Journal of Food Safety 28:389-399.

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