Senior QA Auditor II - (02509311)

Min Salary: $95000.00
Listed Date: 8/5/2017
Degree: Bachelor Biol
Comments
Regulatory affairs and quality assurance professional with over 20 years industry experience.
Specialized expertise with the following regulations and standards:  US FDA (GLP, GMP, GCP), US FDA EPA (FIFRA and TSCA), OECD GLP and EU, Health Canada, MHLW, ICH, ISO 9001:2008, ISO 13485, DEA, CLIA, OSHA, etc.

Director, Global Regulatory Affairs & Quality Assurance. Biotechnology Company specializing in immunoassay products and services
• Provides regulatory consultation for CTL Executive Management and CTL clients.
• Directs the resources and budgets for the regulatory affairs and quality assurance departments for CTL:  CTL Analyzers (manufacturing), CTL Laboratories (research testing), and CTL Reagents (manufacturing).
• Oversees the QA inspection programs for all CTL departments, both internal and external inspections
• Oversees and monitors the Health and Safety Plans for Laboratory Safety and OSHA compliance, including chemical/biological/waste management, hazard communication, etc.
Director, Quality Assurance.
 • Directed the regulatory affairs and quality assurance departments for CTL:  CTL Analyzers (manufacturing), CTL Laboratories (research testing), and CTL Reagents (manufacturing). Provided daily consultation for all CTL locations, both domestic and international, including CTL Europe, CTL China, CTL Hungary, etc.
 • Created and implemented an external audit program for vendors and contractors. Audited off-site document storage facilities, analytical chemistry laboratories, animal facilities, software vendors, etc

Director, Quality Assurance. Contract Research Organization (CRO) specializing in electrophysiology testing
  • Provided guidance on analytical test method validation and acceptance criteria for sample testing. Coordinated with Laboratory Management to validate test methods and cell lines for electrophysiology testing.
• Developed and maintained the Quality Assurance Unit (QAU) by performing both study-specific and internal facility inspections and issued reports accordingly.

Regulatory/Environmental Coordinator..Cleveland Pharmaceutical Services
• Managed clinical trial contracts, confidentiality agreements, master service agreements, Investigator Brochures, etc.
• Prepared regulatory packets for both local and commercial IRB submission/approval.

Quality Assurance Manager. Contract drug manufacturer
Clinical Research Technician