SH.DAVIS Resume K
- 1. Shawniquad@hotmail.com Shawniqua Davis (619) 723-9899 SCIENTIFIC OPERATIONS/TECHNICAL BACKGROUND Participate inthe development of clinical andnon-clinical laboratorystudiesthatsupportresearchor marketingpermitforproductsregulatedbythe FDA andare consistentwiththe OECDand MHLW GMP & GCLP standards. Manage clientspecificresearchprojectsforgovernmentapproval process. Compliance programimplementation,monitoring,andauditing –Deviations,Non-Conformance, CAPA,RiskAssessment,RootCause Analysis Reportsformaterialandprocessesranging fromraw material tofinishedproduct thatdoesnotmeeta specifiedrequirement(QSRandISO) ina medical device GMP andGLP environment. Investigate violationsof companypolicies,lawsandregulations. DevelopandImplementQualityMetric; MaintainMasterSchedule;StudyPhase (In-Process). Delivertrainingoncorporate code of conduct. Generate DocumentControl StandardOperatingProcedures(SOP) andBatchRecordReview. EquipmentandProcessValidationincludinggenerating,executing,anddocumentingInstallation qualifications(IQ),Operational qualifications(OQ),andPerformance qualifications(PQ). Performbacterial analysisof tissueculture andbodyfluidsaccordingtoCLIA methodology. Performbacterial analysisof foodproductsusingAOACmethodology. Analysisof watersamplesaccordingtoUSPand ELAP methodology. PerformMolecularPathogenAnalysis,InterpretandReportResultsof CleanRoom, Sterile Processes for Microbial Identification,MoldCharacterization,SterilityTesting,Microbial LimitingTest,Bax-PCR, ELISA,ECL, VitekII,Reveal RapidDetection,Chemical Analysis,GrowthPromotion,Bioburden,TOC, Microscopy,Endosafe-PTS,Electrophoresis,Spectroscopy. Compliance Standards: ISO 9001 & 13485, GMP, GCP, GLP, FDA, OSHA,CLIA, CMS, IVDD, MHLW, OECD EDUCATION Doctorate ofEducational Leadership and Management 7/ 2014 Alliant International University. San Diego, CA. Master ofForensic Sciences 9/ 2010 National University. San Diego, CA. Bachelor ofClinical Laboratory Science/ Medical Technology 4/ 2006 Bethune Cookman University. Daytona Beach,FL. CREDENTIALS ASCP and California Clinical Microbiology & Medical Laboratory Technician 12/2015 COMPUTER SKILLS Various ERP Systems: Master Control, J.D. Edwards,Agile, Camstar,StatLia, ALIS, Watson, QCBD Microsoft: Windows XP/Vista, Word, Excel, PowerPoint,Publisher Networking
- 2. RELATED EXPERIENCE Intertek Immunochemistry Services., San Diego, CA 5/2014 – 12/2014 Senior Quality Assurance Associate Participate in the development of clinical and non-clinical laboratory studies that support research or marketing permit for products regulated by the FDA and are consistent with the OECD and MHLW GLP standards. Alere, Inc., San Diego, CA 10/2012 – 5/2014 Quality Assurance Specialist Identify, Risk Assess,Disposition, and Report the logistics of non-conforming materials or conditions that does not meet a specified requirement (QSR and ISO) in a medical device GMP and GLP environment. Material and processes range from raw material to finished product. Ultimate Labs, Inc., San Diego, CA 6/2008 – 3/2012 Operations Microbiologist Supervisor/ Operations Microbiologist Manage client specific research projects for government approval process. Perform Molecular Pathogen Analysis, Interpret and Report Results. Henry Jackson Foundation for the Advancement of Military Medicine,San Diego, CA7/2007-10/2007 Microbiology Laboratory Technician Basic microbiology procedures according to Standard Operating Procedures including microscopic work, pipetting, tissue culture techniques, streaking plates, virus isolation, and identification for the Department of Respiratory Disease Research. Bethune Cookman University., Daytona Beach,FL 8/2005 – 5/2006 Microbiology Lab Assistant Provide pro-types for teaching staff in Biology/ Clinical Laboratory department including Clinical Microbiology, Blood Bank, Hematology, Immunology, and Urinalysis. Maintain logs and updates on lab equipment and reagents; Operated autoclave systems; Disposal of hazardous material RELATED EXPERIENCE IN EDUCATION Alliant International University., San Diego, CA 1/2014 - Current Biology Adjunct Faculty General Biology Lecture and Laboratory Online and On-site; Traditional and Non-Traditional Student Restore Our Youth, Inc., San Diego, CA 4/2012 - Current CEO, Founder, and Faculty Member Develop program, organizational, and financial plans with the Board of Directors and staff toward consistent achievement of trends in the Science, Technology, Engineering, and Mathematics education and career field. San Diego County Office of Education., San Diego, CA10/2007 – 3/2012 California High School Exit Exam (CAHSEE) Tutor Coordinator Develop, execute,analyze San Diego – North Region JCCS CAHSEE Prep program for 10th through 12th grade students to enhance academic strengths and remediate academic deficiencies in Mathematics and English for students to achieve goal of passing the high school exit exam. Manage a team of part-time staff Assist in the development of the CAHSEE Services budget
- 3. Spectrum Pacific Learning Company., San Diego, CA 10/2012 – 6/2010 Technical Writer Train-the –trainer: Handle the learning and professional development of an organization’s workforce, in particular professors,to e-learning platform. Perform instructional design ORGANIZATIONS US Army - Reserved Officer Training Corp. Daytona Beach, Florida 08/2000-5/2003 Received extensive leadership training in order to achieve goal of commissioning as 2nd Lt. Awarded a four year education scholarship Passions: Leading people and organizations to higher performance levels Resolving issues and creating sustainable ‘success’ Building relationships with different organizations, departments, and all position levels