Robin Williams CQA (ASQ), MLT (ASCP)

Experience

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  Moses Taylor Hospital

  Jan 2007 - Jan 2009

  Medical Technologist

  Performed clinical laboratory testing in 214-bed, acute care hospital.• Obtained and accessioned samples by diligently verifying patient identity against orders, ensuring traceability, and preventing sample mix-ups.• Tested clinical specimens utilizing various methodologies and instrumentation, following laboratory departments (hematology, chemistry, blood bank, microbiology, urinalysis) protocols, providing physicians with prompt and accurate test results to better serve patients. Show less

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  American Red Cross

  Jan 2010 - Jan 2019

  Quality Manager

  Supported quality director and interfaced with senior management. Exercised independent judgment with minimal supervision. Guided associates on quality issues. Assured department staff was adequately trained and adhered to all company, local, state, and federal regulations and OSHA standards (through June).• Managed quality systems and regulatory affairs activities which consisted of Material Review Boards (MRBs), licensure / registration activities and review and approval of records, processes, and systems, ensuring all processes within organization were consistently operating in state of control, meeting donor and recipient needs.• Created synergistic team by training and mentoring quality associates across 5 geographic locations in quality principles and regulatory requirements to serve as subject matter experts (SMEs), providing direction and guidance to operational departments.• Prepared, hosted, and closed out internal and external inspections / audits, verifying facility regulatory compliance was maintained.• Developed collaborative environment among multidisciplinary departments through mutual respect, effective communication strategy, and honoring open door policy, ensuring process improvement initiatives would continually be effective.• Empowered staff to take ownership and cease manufacture and / or distribution of biomedical products / services when it was determined safety, quality, identity, purity, potency of product or process had been compromised by using leadership and critical thinking skills and consistently coaching staff on good manufacturing practices (GMP).• Monitored organizational changes to facilities, equipment, and processes, confirming regulatory agency notification, equipment validation, communication to all stakeholders, guaranteeing smooth transition. Show less