SUMMARY Certified Quality Auditor for Life Science Practice Lead as senior Quality System Auditor with compliance acumen delivering outstanding returns through comprehensive knowledge and hands on experience. Vendor qualification and management plus remediation efforts ensuring delivered products meet requirements for direct to stock fulfillment. Certified Quality Auditor/Project Manager for Quality Management Systems for manufacturing operations and IT infrastructure dealing with life science industries in global marketplaces. Supply Chain/Vendor qualification and annual evaluation assessment for inclusion on approved supplier listing to support production and R&D purchasing. Champion audit and remediation activities to ensure FDA inspection readiness and CAPA remediation. Accomplished leader/facilitator experienced in oversight, management and manufacturing of implementation quality systems, operations/production, quality, validation, calibration, safety, training, GDP, GxP, CAPA, root cause analysis, and lean initiatives.

Highlights:

• Audit
• Quality
• Quality Assurance
• Services
• Test
• Compliance
• Infrastructure
• Management
• Risk Management
• Training