SUMMARY I have a Quality Assurance background (various areas of QA) with experience managing and overseeing QA processes in a Pharmaceutical and Medical Device regulated environment. Produce statistical documentation and communicate with senior-level managers regarding Quality Assurance/Training issues. Provide supervision and training to QA group members. Sustain quality and compliance levels. I am skilled in the following areas: * Policy/Procedure Development * Change Control and Global Change Control * Solid Dose, Liquid Dose, Sterile Product, Aerosol, Transdermal Patches, Injectable Products, Medical Device * Microbiology Operations * Trackwise: CAPA, Investigations and Change Control * Documentation * Validation (IQ, OQ, PQ) * Sharepoint, Teamspace * MIDAS * Internal/external customer Complaints * Knowledge of Blueprint, GD&T symbols and rules * QUMAS, Documentum * Training Database System Administrator/User: MyLearning, Eduneering, Trac 6.4, TM2000 * GMP Training * Process Improvements * Audit - internal and external * Batch Record and Device History Record Review and Release * Metrics and Trend Analysis * SAP user * 21 CFR Part 210-211, 21 CFR Part 11, 21 CFR Part 58, 21 CFR Part 820, ICH Q7, Q8 (R2), Q9, Q10, ISO 9001, 17025, 13485

Highlights:

• Manufacturing
• Test
• Management
• Audit
• Validation
• Database
• Documentation
• Microsoft Office
• Quality
• Quality Assurance
• Investigations
• Microbiologist