Juli Boone Email & Phone Number

SUMMARYDirector of Quality Assurance. Extensive experience in QA. Proven track record of attaining and maintaining ISO 9001 certification and ISO 27001 certification, conducting internal audits, managing external audits, managing the nonconformance and corrective action programs. Creating and documenting company policies, procedures and detailed work instructions. Determining and implementing adherence to Rules & Regulation for compliance to state and federal requirements in regulated industries. Strong background in equipment, drug and medical device validation, and breath alcohol ignition interlocks devices (BAIID).SKILLS INVENTORYISO 9001 QMS Certification & maintenanceISO 27001 ISMS Certification & maintenanceProject ManagementProblem Solving & Root Cause AnalysisIQ and OQ Protocol ExecutionPQ, Process ValidationAnalytical Method Development & ValidationLab ManagementSpecialties: ISO 9001 QMS Certification, ISO 27001 ISMS Certification. Maintenance, & Compliance, IQ, OQ, PQ, FAT, SAT Development and Execution, Project Management, Personnel Training & Competence, Quality Control & Assurance, TOPs (Turn-over packages), Validation, Technical Writing, SOPs, WIs

Listed skills include Validation, Sop, Documentation, Troubleshooting, and 5 others.