Dawn Kanupp

About Dawn Kanupp

Over 25 years of Quality Assurance experience in multi-product facilities with both clinical and commercial operations. Experienced professional with a diverse background in the oversight of manufacturing biologics, pharmaceuticals, CMOs, and medical devices; including: DS, DP, OSD tablets and capsules, active pharmaceutical ingredients for pediatric and adult vaccines, antibiotic and oncology parenteral drug products (aseptically manufactured and terminally sterilized), as well as in-vitro diagnostic medical devices. Develop strong collaborative teams with internal, external partners and sister sights across the globe. Highly motivated individual with initiative to succeed in a fast-paced environment. Excellent analytical, risk-analysis, prioritization, multi-tasking, and leadership skills. Superior technical writing, root cause analysis, investigation and peer-coaching skills.Result-orientated team player with strong communication and problem solving skills. Demonstrated ability to work as an individual contributor while managing cross-functional teams. Organized and efficient in daily activities.M.S. Quality Assurance & Regulatory Affairs, Temple University School of Pharmacy.Specialties: CMO Management and Quality Oversight, Conducting Business Review Meetings, Product Quality Review, Quality Agreements, authoring JP MOH Memo of Understanding, Module 3 QC data review, Quality Systems, GMPs, GCPs, technical writing, Root Cause Analysis, investigations, CAPA program, generating and reporting site metrics in QMR setting, conducting internal and external auditing, audit defense SME presentation, validation review/approvals (cleaning, process, equipment and method), batch record disposition, EM data review and response, product complaint management and investigation, facilities and utilities support (Preventive Maintenance, Work Orders, Calibrations) for multi-product/client areas.Proficient in MS Office 365, TrackWise, Labware LIMS, Minitab, SAP, Blue Mountain (Calibration Manager and Regulatory Asset Manager), Documentum, Veeva.

Experience

1. Manager External Manufacturing

   Eisai US

   Jul 2018 — Present · Raleigh, NC, US

   Responsible for quality oversight of active pharmaceutical ingredients and finished drug products manufactured by external contract manufacturing organizations for commercial and clinical distribution.

Education

• Temple University

  MS, Quality Assurance/Regulatory Affairs

  2003 — 2006

• Bowling Green State University

  BS, Biology

  1993 — 1997

Skills

• Corrective and Preventive Action (Capa)
• 21 Cfr Part 11
• Capa
• Validation
• U.s. Title 21 Cfr Part 11 Regulation
• Pharmaceutical Industry
• Sop
• Fda
• Gcps
• Quality System
• Vaccines
• Gxp
• Aseptic Processing
• Manufacturing
• Computer System Validation
• Change Control
• Auditing
• Calibration
• Trackwise
• Lims
• Standard Operating Procedure (Sop)
• Work Orders
• Good Clinical Practice (Gcp)
• Technology Transfer
• Preventive Maintenance
• Documentum
• U.s. Food and Drug Administration (Fda)
• Gmp
• Laboratory Information Management System (Lims)
• Quality Assurance