Experience

Mikart, LLC

• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Director of Quality Control

  • Jun 2019 - Present

• Director of Quality Control

  • Sep 1997 - Present

  15 years DEA Authorized Quality Director with versatile administrative, and practical lab management expertise. Lead and developed the Quality Management Group including Quality Assurance, Quality Control, as well as Analytical Research and Development. 20 plus years of FDA inspection experience. Liaise with Clients and Regulatory in support of all phases within new drug development, method validations and method transfer activities per cGMP and USP compliance. Strong analytical problem-solving and decision-making skills coupled with the ability to work both independently and in a team environment. A highly skilled change agent with demonstrable sensitivity to the interpersonal, group dynamic, organizational, political, and perceptual issues associated with change. Thorough understanding of regulatory requirements for manufacturing processes and controls of pharmaceutical drugs, devices including quality risk management and application of regulatory expectations to the Quality system. Show less

• Director Of Quality

  • Oct 2004 - Oct 2016



Carson Products

• United States
• Accounting

• Chemical Specialist

  • Feb 1995 - Apr 1997

  Chemical Specialist / Quality Assurance Performed Physical and Chemical Analysis on test samples of production batches and raw materials. Chemical Specialist / Quality Assurance Performed Physical and Chemical Analysis on test samples of production batches and raw materials.