Summary * More than eight years of Quality Assurance (QA) and regulatory experience abiding by GCLP, GLP, GMP, ISO/IEC 17043, GxP, and HIPAA. * Excellent problem solving, risk analysis and organization skills * Strategic thinker with strong interpersonal skills * Able to initiate and complete assigned tasks, work independently, and maintain team orientation skills * Professional, flexible and creative

Highlights:

• Standard Operating Procedures
• Quality Management Plan
• Quality Assurance
• Internal, in-process, External, Vendor Audits
• ISO
• Word, Excel, Power Point
• Study-Specific Plans
• Good Laboratory Practices
• Good Manufacturing Practices
• Quality Assurance Training