Celena Smith Email & Phone Number

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 of drug development, method validation and/or method transfers. Key Skills • Leader of Quality Management review and ensures implementation of GMP related CAPAs for key process areas, emerging trends, and areas of high impact using risk-based methodologies• Implement Data Integrity principles/cGMP practices• Establish departmental metrics and KPI’s• Interfaces with environmental and safety agencies:OSHA, DEA/EPA/FDA• Provide inspection support for Regulatory Agencyinspections for FDA & DEA• Hiring, career development, performance review andterminations for Quality Division• Interface with several regulatory agencies• Root Cause Analyses (RCA) utilization of Kepner Trego technique solving laboratory and manufacturing OOS investigations• Develop operating and capital expense budgets to support major instrumentation and software purchases• Product development analysis• DEA Authorized• Complex Processes/Project Management Skills• Experience with Regulatory approval support (ANDA, NDA, IND,and MAAs)• Quality oversight during all phases for newmicrobiology laboratory.

Listed skills include Gmp, Fda, Sop, Capa, and 15 others.

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  Savannah State University

  Chemistry