Bethany Mcelroy Email & Phone Number

Results oriented professional with extensive Quality and Manufacturing experience in the biotech/pharmaceutical industry; ranging from start-ups to global, multi-national companies; clinical, commercial and contract manufacturing products. Expertise includes diverse roles of increasing responsibility in Quality Assurance, Quality Control, and Manufacturing.STRENGTHS• Quality Systems expert for Inspection Readiness, Product Complaints, Annual Product Quality Reviews, CAPAs, Compliance Audits, Document Change Control, and Discrepancy Management• Recognized for in-depth knowledge of inspection management strategies and Health Authority (HA) regulations and guidelines (FDA, EMA, Swissmedic, COFEPRIS, ANVISA, ICH, etc.) • Continuous improvement advocate – Apply LPS principles/methods to identify gaps and improve efficiency• Technical writing skills – authoring and approving GxP reports, policies, procedures, and work instructions• Insights Discovery© Evaluation: Reforming Observer. Top strengths include being realistic and systematic, concise and incisive in communication, good situational analyst, and effective problem solver.