Bonny Harris

About Bonny Harris

I am an accomplished Quality professional Driving Regulatory Inspection Excellence and…

Experience

1. Supplier Quality Manager

   Johnson & Johnson

   Aug 2015 — Present

   Responsible for implementation and maintenance of North American Chemical Supplier Quality Management Program, ensuring continued corporate and regulatory compliance.Qualify new suppliers, implement supplier control strategies, monitor supplier quality scorecards and drive supplier quality improvement projects.Negotiate and ensure compliance of supplier Quality Agreements ensuring continuous high quality supply of raw materials supporting manufacturing.Review and approve; change controls, raw material specifications, non-conformance\'s, CAPA, audit action items and risk assessments/mitigations ensuring timely and effective closure.Lead standardization of processes and supplier improvement task forces resulting in supplier quality excellence using Six Sigma Black Belt approaches.

Education

• State University of New York College of Agriculture and Technology at Cobleskill

  Associate's degree

• Rochester Institute of Technology

  Bachelor of Science (BS)

Skills

• Quality System
• V&V
• Regulatory Compliance
• Pharmaceutical Industry
• Business Process Improvement
• Fda
• Testing
• Biotechnology
• Medical Devices
• Capa
• Validation
• Technology Transfer
• Quality Assurance
• Iso 13485
• Supplier Quality Management
• Risk Management
• Quality Control
• Gmp
• U.s. Food and Drug Administration (Fda)
• Quality Management
• Critical Thinking
• Cross-Functional Team Leadership
• Consent Decree
• Process Improvement
• Preapproval Inspections
• Verification and Validation (V&V)
• Six Sigma
• Quality Auditing
• Corrective and Preventive Action (Capa)
• Change Control
• Design Control
• Root Cause Analysis
• Manufacturing
• Quality Management Reviews
• Inspection Readiness