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Candidate's Name
Street Address  PHONE NUMBER AVAILABLE EMAIL AVAILABLEDetailed oriented and driven Quality professional seeking position of SenioSpecialist.EDUCATIONShaw University, Raleigh, NCAug. 1992  May 199Bachelor of Science in BiologyCourses: Epidemiology and Biostatistics, Organic, Analytical, and Biochemistry, Physiology, Microbiology, Vertebrae Anatomy, Embryology, Genetics, Immunology, Zoology, Ecology, Botany, Biology Seminar, and Microcomputer SoftwareJohnston Community College, Smithfield, NCMay 2011 2011Associate of Arts: ASQ AuditingRelevant Courses: Writing audit plans, audit team segment, schedule follow up assignmentNorth Carolina State University, Raleigh, NCAug. 2012  2012Associates of Arts: International Organization for Standardization (ISO) for 14001 AuditingRelevant Courses: Conducted audit with audit team, finding deviations from procedures, writing audit plans, scheduled follow up of corrected errorsJohnston Community College, Smithfield, NCMarch 2017- May 2017Six Sigma: Total Quality FundamentaJohnston Community College, Smithfield, NCMay 2017- July 2017Medical Writing: American Medical WritersAssociationJohnston Community College, Smithfield, NCAugust 2017-October 2017Six Sigma: Total Quality ApplicationsPROFESSIONAL CERTIFICATIONISO for 14001 AuditingJan. 2012 - 2012WORK EXPERIENCEGrifols Therapeutics Clayton, NCQuality Associate IIINov. 2008  presentAudit batch production recordsAudit laboratory testing records for accuracyFollow Standard Operating ProceduresPrepare batch paperwork for final release of productsWorks in a cGMP environment, where FDA21 CFR Part 11, 210, and 211 laws are followedUse of systems, such as SQL, LIMS, SAP, Trackwise, EDMS document control system, CITRIX, Charge Control application and Microsoft OfficeParticipated in ISO 14001 monitoringCommunicate with production and laboratory personnel for discrepancies and followed up on correctionsDaily communicated with customers internationally and domestic.Train colleagues on auditing batch production records and testing paperworkConduct departmental safety meetingsKnowledge of Europe, Canada, United States and other countries requirements and specificationsPrepare and create training modules for department.Represented department at weekly product release meetingGrifols Therapeutics, Clayton, NCQuality Associate IIAug. 2005- Nov. 2008Audit batch production recordsAudit laboratory testing records for accuracyFollow Standard Operating ProceduresUse of specific systems such as SQL, LIMS, SAP, Trackwise, EDMS document control system, CITRIX, Change Control application and Microsoft OfficeShipped samples to FDA for testingCommunicated with production and laboratory personnel for discrepancies and followed up on correctionsKnowledge of Canada, Europe, and United States and other countries requirements and specificationsConduct departmental safety meetingsGrifols Therapeutics / Talecris Biotherapeutics, Clayton, NCQuality Technical Compliance CoordinatorMay 2003  Aug. 2005Participated in auditsAudited laboratory results (PCR) and entered in SQL LIMS for approvalCommunicated with plasma centers, laboratories, and other departments for errorsDocument management for the records stored and retrievedBayer Healthcare, Raleigh, NCLaboratory Support TechnicianAug. 2000  May 2003Selected as Laboratory Support Department Trainer for SQL LIMSTrained over 150 employees on SQL LIMS including departmentWorked in validation for testing of SQL LIMS systemScanned plasma samples into LIMS for laboratory testingInitiated detailed problem reports and communicated corrections needed with plasma center managersParticipated in Annual Batch ReviewChosen as a consultant for the Kaizen committee, to help reduce paperwork, in order to streamline processesBertie Memorial Hospital, Windsor, NCOutreach Records ManagerSept. 1999  Aug. 2000Managed diabetic education departmentInterviewed and educated diabetic patients on the importance of their healthFacilitated diabetic groups on nutrition, medicine, health, and glucometer useScheduled appointments with specialists for patientsAttended OSHA in-servicesTRAININGELISA, CMV, Anti-C and Anti-D Testing January 2002Six Sigma: Total Quality Fundamentals. August 2017- Oct 2017Six Sigma: Total Quality Applications March 2017-June 2017Medical CodingCOMPUTER SYSTEMSMicrosoft Office (Word, Excel, Publisher, PowerPoint, and Access) LIMS, SAP, Trackwise, CITRIXChange Control system, Document Control Management systemCOMMITTEE MEMBERSHIPSKaizen Committee 2001- 2003GOALSTo attain ASQ Auditor certificationREFERENCESAvailable Upon Request