Manager, Quality Systems
CurrentAutumn Harp – Essex Junction, Vermont (13 Years)Manager, Quality: 2003 – 2006Manager, Quality Systems: 2006 – 2016Senior Level:FDA / ISO management and administrationSenior Quality Representative to various companies including (many Fortune 100 companies)Corrective and preventative management systems administration and management including chairmen of the corporate CAPA team consisting of all operations departments.Customer complaintsSupplier quality management Senior quality risk assessment and control point developmentOperational quality systems administration and management including: ISO, FDA, HACCP, SQF Level 3, organic, OSHA and EPA systemsInternal and external (supplier and contract services) auditing Lean manufacturing and activity based quality cost accounting process management. Milliken Operational Excellence Practitioner Manufacturing process and equipment verification / validation Product validation and verificationInformation systems (including ERP/MRP) validation / verification Pilot process and product validation Project management administrationIndustrial hygiene / microbiological / pest control Employee training system development and Implementation, continual skills developmentAdministrative, process, and engineering change controlsExtensive experience managing up to 14 quality employees and a budget approaching $750,000Extensive and successful employee and team management experience Calibration, pest control, industrial hygiene processes includiing manufacturing and product microbiological administration and managementDrug actives testing Document control review and approval and records Industrial process controls and trainingInternal quality auditing (ISO lead auditor accreditation)Pilot and new product development oversight (Quality Engineer representation