Ginger Smith
Director of Quality Assurance (QA) and Compliance

Ms. Ginger Smith

Ms. Ginger Smith, is a Scientist and the Director of Quality Assurance, an exceptional talent and proven Quality Assurance leader with ten years of experience working in the biotechnology industry, microbiology labs, and highly regulated environments by the Food and Drug Administration (FDA).

Before joining T&T Scientific, Ms. Smith directed projects and research for biotech manufacturing, working directly with regulatory consultants from the United States, Canada, and Europe (ECHA). Ms. Smith has worked alongside executive leadership, the internal Science Medical Advisory Board, and all levels of management in establishing workflow processes, projects, and corporate and quality policies. Moreover, Ms. Smith has worked with multiple departments in the biotechnology industry to develop and acquire reports and establish precise planning, timelines, and results regarding quality assurance and quality control to achieve team requirements for regulatory bodies and clients.

Contact Quality Assurance Unit

Areas of Expertise and Interests

  • Quality Assurance in Highly FDA Regulated Laboratories Environments
  • Current Good Manufacturing Practices (cGMP) Gap Assessment, Quality Audits, and Quality Assurance Improvement
  • Research-based on Efficacy, Effectiveness, and Safety of Biotech product line
  • Planning and Organizing National and International Laboratory Manufacturing and Quality Control Testings
  • Current Good Manufacturing Practices (cGMP) in Pharmaceutical and Biotechnology Industries
  • Quality Assurance Leadership
  • Client Relation Management (CRM) with Various Clinical+ Stage Clients' Quality Departments
  • Development and Execution of Regulatory Documents, including internal cGMP Quality System, Environmental Protection Agency (EPA), FDA Design Control, and OSHA regulated Safety.
  • Identification, Evaluation, and Developments Relations with Quality Vendors
  • Gap Assessment and Improvement in Internal Quality System and Departments
  • Gap Assessment and Improvement cGMP Facility Compliance and Safety Following Guidelines from FDA, USDA, Occupational Safety and Health Administration (OSHA), and other guidelines by continuously evaluating processes and developing accurate documentation to track trends and progress
  • Leadership: Facilitated Communications and Projects with the Company's Science and Medical Laboratory and Advisory Board