Lisa McKee

Experience

• 

  Caliper, Inc.

  Mar 1997 - Apr 2001

  Business Adminstration
• 

  Dr. A. Schuette

  Apr 2001 - Feb 2004

  Office Manager
• 

  Henry Schein, Inc.

  May 2005 - now

  (Continued from Above) - see above Responsible for the upload of SOPs and Testing into internal electronic document PowerDMS system. and create certification courses for each Distribution, Operations, and Regulatory departmental functions. *I can train any new employee/temp or cross-train any current employee of the Regulatory Affairs Dept. for job functions that pertain to my knowledge, experience and training. *Assist the Distribution Centers during government inspections, and reviews inspection report observations. *CAPA, recommend appropriate and timely response; and provides guidance implementing proper corrective and/or preventative action. *Assist with contacting and consulting with Federal, State, and local government agencies (i.e., FDA, DEA, EPA, DOT, FAA, NABP and State Pharmacy Boards) and International Regulatory agencies to obtain appropriate documentation to update and acquire company licensing and accreditations in order to handle, store, ship, and repair regulated products and equipment. *Research applicable Federal, State and Local regulations; assist in developing and implementing the necessary policies and procedures to ensure the Company’s ongoing compliance with recent changes. *Provide support to Operations, Marketing and the Business Units answering questions pertaining to regulatory issues, such as MSDS, FDA, product classification, registration and disposal, as well as other DOT, FAA, EPA and OSHA related matters. *An Internal Auditor and conduct routine Regulatory/Internal audits of operations. *Participate in special projects and performing other duties as required. *In addition to the essential duties and responsibilities listed above I have the ability to analyze problems and to develop solutions. I take the time to research the problem and try to find the cause of the problem and then find a solution to correct the problem in a very timely manner. Show less

  • Sr. Regulatory Affairs Associate

    Jul 2019 - now

  • Regulatory Affairs Associate

    Apr 2016 - Jul 2019

  • Sr. Regulatory Affairs Assistant

    Mar 2012 - Apr 2016

  • Regulatory Affairs Assitant

    May 2005 - Mar 2012