A successful Documentation Control Management professional with over 30 years of experience in the Pharmaceutical and Medical Device industry. Excellent communication and interpersonal skills. Committed to motivating and empowering employees to consistently meet or exceed customer expectations and business needs with the following experiences: Quality Management Systems (QMS) development and implementation (QMS was based on CFR 820/QSR ISO 13485) effectively managed and participated in numerous internal and agency audits. Responsible for documentation control process improvement and CAPA. Responsible for product change control (included Engineering Change Order Variance Authorizations Plans and Reports). Communicated to superiors statistical metrics for Documentation Control informed management of areas requiring improvement. Utilized Lean Six Sigma techniques to streamline processes.

Highlights:

• Documentation
• Management
• Project Management
• Pharmaceutical
• documentation control
• documentation management
• quality systems