Melissa Kohler
Director of Quality Control @ADMA Biologics, Inc.
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WORK HISTORY
Director of Quality Control @ADMA Biologics, Inc.
EDUCATION
UMass Boston
Bachelor of Science (BS), Biology, General
ABOUT MELISSA KOHLER
Pharmaceutical and biotechnology Quality professional with over 20 years of leadership, technical and operational experience. Extensive expertise in both Quality Control and Quality Assurance for clinical/commercial manufacturing and testing of biological and gene therapy products.• Extensive knowledge of analytical methods: bioassay, flow cytometry, qPCR, and ELISA.• Extensive experience with lab investigations/OOS, deviations, CAPA, change controls, and analytical instruments and method validation.• Direct experience in supporting client and regulatory inspections, including PLI inspection.• Committed and flexible individual capable of leading high-performing teams as well as supporting cross functional departments. Strengthened the QC organization by the implementation of continuous improvement initiatives and integration of Human Performance principles.• Broad experience with EQMS (Veeva, EtQ, TrackWise, PLM), EDMS (Veeva, myCIMS, eDocs), ERP systems (Oracle PLM), ELMS (Compliance Wire, ISOtrain, SuccessFactors), LIMS, Empower, NuGenesis.
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