Lisa D. Coutts

About Lisa D. Coutts

Experienced Quality Assurance and Compliance Professional with a demonstrated history of working both the chemical and pharmaceutical industries. Skilled in compliance documentation, QA review, project management, process improvement, hazard communication and product safety. Professional with an advanced degree in Organic Chemistry and pharmaceutical / chemical manufacturing experience with the ability to speak the language of scientists, analysts and quality professionals to understand the issues and technical details and generate effective solutions. Proven ability to plan, develop, and execute projects and activities to meet aggressive timelines and specifications. Collaborates seamlessly with global vendors, contractors and customers. Motivated by active learning and a team approach to goal attainment.SPECIALTIES: Compliance, Quality, Strategic Planning, Data Analysis, Good Manufacturing Practices (GMP), Chemistry, Manufacturing and Controls (CMC), Quality Systems, Scientific Writing, Validation, 21 CFR 11, EU GMP, ICH Q7, Hazard Communication, Product Stewardship, Safety Data Sheet (SDS) AuthoringCompleted \"Sterile Products: Formulation, Manufacture and Quality Assurance,\" CfPA, Edison, NJ, September 2019Completed \"CMC Simulation: A Hands-on Approach to Global Marketing Applications,\" and,\"CMC Writing and Submission Strategies: A Global Regulatory Approach,\" CfPA, Edison, NJ, October 2019MSDgen (Verisk 3E SDS software), WERCS and SAP platform experience

Experience

1. Senior Quality Assurance Specialist

   Sharp Sterile Manufacturing

   Jan 2020 — Present · Lee, MA, US

   Manage quality systems in compliance with cGMP standards requirements.• Ensure in-process and finished products and processes conform to in-house policies and procedures as well as applicable regulations and guidelines. • Manage Quality System Events (Deviations)• Ensure that cGMP requirements and quality standards are recognized, understood and maintained.

Education

• University of Oregon

  Bachelor of Science (BS), Chemistry

• Syracuse University

  Doctor of Philosophy (PhD), Organic Chemistry

Skills

• Hazard Communications
• Laboratory
• Risk Management
• Technical Writing
• Product Stewardship
• 40 Cfr
• Biotechnology
• Ehs
• Training
• International Shipping
• Software Documentation
• Iata
• Manufacturing
• 29 Cfr
• Operations Management
• Quality Assurance
• Pharmaceutical Industry
• Fda
• Capa
• Pharmaceuticals
• Global Operations
• Dot Compliance
• Lc-Ms
• Gmp
• Validation
• Cgmp
• Compliance
• Msds
• Project Management
• Cross-Functional Team Leadership
• Imdg
• Regulatory Affairs
• 21 Cfr Part 11
• Process Improvement
• Documentation
• Hazardous Materials
• Technology Transfer