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Skills

  • Statistical Process Control (SPC)
  • Automation Systems Validation
  • Cross-functional team collaboration
  • Quality assurance and control
  • Continuous Improvement Initiatives
  • Monitoring key performance indicators (KPIs)
  • 3M Encoder
  • Operational improvement
  • Medical billing code accuracy
  • Communications

Work Experiences

  • Went over the charts and highlighted any information that was missing or incorrect.
  • Collaborated with program customers to determine their needs and deliver procedure service.
  • Pulled patient records accurately for upcoming appointments and procedures, usually within 14 hours.
  • Achieved results within 5 months.
  • Looked for industry trends on social media and through online sources.
  • Collaborated with cross-functional teams.
  • Collaborated with cross-functional teams to validate critical components of a Asana, improving overall delivery time by 28%.
  • Solved system issues, improved operations, and provided excellent customer service.
  • Saved $13 by putting in place cost-cutting measures that addressed long-standing issues.
  • Collaborated with R&D teams to validate prototypes of Workday, accelerating time-to-market by 17 months.

Summaries

  • Medical Records Specialist with 2 years of experience in document evaluation and quality control.
  • Contributed to a 36% decrease in product defects.
  • Contributed to Beacon Labs saving $10.
  • Dedicated performer with experience processing subpoenas and court orders.
  • Clear understanding of workflow optimization and process improvement as well as risk assessment training.
  • Conducted regulatory audits.
  • Overall morale and productivity are boosted by experience in policy development and staff management procedures.
  • Committed Validator with a history of contributing to innovation, leading the integration of new products that earned industry recognition such as Top Performer in 2019.
  • Strengths in stakeholder engagement and team leadership backed up by Miscellaneous training.
  • Dedicated to enhancing product lifecycle management through effective validation practices, contributing to Cedar Works saving $14 by minimizing manufacturing inefficiencies.

Accomplishments

  • Documented and resolved initiative which led to metric.
  • Chaired validation review board meetings, ensuring cross-department harmonization of best practices, which resulted in 11% project completion earlier than forecast.
  • Conducted root cause analysis for framework deviations, implementing solutions that reduced recurring errors by 51%.
  • Trained cross-functional teams on validation best practices, improving test accuracy across 2 projects and reducing average defect rate by 70%.
  • Led internal audits following validation, which resulted in a 65% increase in compliance with ISO standards and regulatory guidelines.
  • Partnered with QA and production teams to implement validation strategies that improved product defect detection rates by 60%.
  • Reviewed and optimized validation documentation lifecycle management, improving change control process adherence and reducing risk by 24%.
  • Implemented data integrity initiatives within validation protocols, reducing audit findings in compliance reviews by 59%.
  • Developed and validated critical manufacturing processes, reducing product yield variability by 28% and increasing overall product quality.
  • Reduced validation cycle times by 68% by re-engineering validation processes while maintaining full compliance with FDA CFR Part 11.

Affiliations

  • American Society for Quality (ASQ)
  • Freemason
  • Institute of Validation Technology (IVT)
  • Deviation Investigation and Root Cause Analysis Certification (2021)
  • Rotary International
  • Certified Quality Improvement Associate (CQIA) (2017)
  • Validation Specialist Certification from Summit Group
  • Project Management Institute
  • International Test and Quality Assurance Association
  • Toastmasters

Certifications

  • Calibration & Instrumentation Best Practices Certification - Lakeside Partners
  • Cisco Certified Network Associate (CCNA)
  • Process Validation: From Planning to Execution Certification - Ironclad Systems
  • Certified Process Validation Professional (CPVP) - Northwind
  • ISO/IEC 17025 Laboratory Accreditation Certification
  • Regulatory Affairs Certification (RAC) - Harbor & Co.
  • ServSafe
  • Certified Manufacturing Technologist (CMfgT) – SME
  • Google Certified Professional Cloud Architect
  • Certified Pharmaceutical Industry Professional (CPIP) - ISPE

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