QUALIFICATION SUMMARY Thirty-five years of pharmaceutical/biotech industry biotech with management experience. Able to adapt to rapidly changing business situations and move forward with change while using strong communication skills to facilitate a high level of collaboration among peers and co-workers. Broad background of experience and expertise in the following areas: * Quality Control/Quality Assurance * Team Development/Leadership/Management * SOP Coordinator * Change Controls/CAPA * Process Improvement * Testing/Validation/IQ/OQ/PQ * Inventory Control * Auditing/FDA Audits * GMP/GLP/GCP Training/Development * Consumer Complaints/Investigations

Highlights:

• Training
• Corrective Actions
• Data Processing
• Good Manufacturing Practices
• Manufacturing
• Quality Assurance
• Test
• Data Entry
• Document Management
• Filing