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