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Skills

  • FDA Regulatory Documentation
  • Compliance tracking and reporting
  • Process improvement
  • Analytical problem solving
  • Customer service
  • Team management
  • Compliance Monitoring
  • Materials inspections
  • Collaborative problem-solving
  • Data interpretation

Work Experiences

  • Achieved zero late submissions for 6 years.
  • Investigated test results that appeared to be suspect.
  • Developed and audited practices, programs, and reporting system metrics for maximum efficiency.
  • Checked the quality of raw materials and finished products and discarded anything that didn't meet safety standards.
  • Authored training materials for quality management systems.
  • Authored and revised Standard Operating Procedures (SOPs).
  • Authored and revised Standard Operating Procedures (SOPs) to align with updated regulatory changes, improving compliance rates by 61% year-over-year.
  • Conducted a visual inspection of products to determine if they met quality standards.
  • Conducted reviews for regulatory bodies in 2020.
  • Conducted internal and external quality audits.

Summaries

  • Analyzed data from internal and external stakeholders.
  • Adept at implementing cloud-based documentation systems.
  • Overall morale and productivity are boosted by experience in policy development and staff management procedures.
  • Accomplished in managing quality documentation systems, consistently achieving 19% accuracy and earning a Top Performer for document control excellence.
  • Achieved zero findings in 2024 of operations.
  • Recognized on a regular basis for outstanding performance and contributions to the Miscellaneous industry's success.
  • Proven leadership, operational excellence, and organizational development skills, as well as a thorough understanding of the method business.
  • Advanced overall compliance standards.
  • Quality Documentation Specialist is a multi-talented Quality Documentation Specialist who is consistently rewarded for planning and operational improvements.
  • Disciplined professional who approaches workflow optimization in a systematic manner.

Accomplishments

  • Reduced the cycle time for document revision and approval processes by 17 days through workflow optimization and employee training.
  • Updated the document control system to meet the new 2024 metric guidelines, improving compliance by 74%.
  • Ensured full audit readiness by overseeing document control for 6 audits, resulting in zero non-compliance findings during 2017.
  • Collaborated closely with regulatory bodies to ensure all quality documents met the latest CPA standards, enhancing compliance results significantly.
  • Directed the documentation of quality certification processes, earning Meridian recognition for regulatory excellence in 2015.
  • Authored and revised SOPs in accordance with framework updates, leading to a 23% improvement in yearly regulatory compliance.
  • Served as the primary point of contact for cross-departmental collaborations on documentation issues, which led to 72% faster issue resolution.
  • Reduced the number of audit findings by 38% through coordinated training programs on document control best practices and protocols.
  • Conducted regular in-house quality audits, leading to 37% fewer incidences of non-compliance within 2 months.
  • Introduced a digital archive system, which increased the accessibility of quality documentation and reduced retrieval times by 10%.

Affiliations

  • Association of Information Technology Professionals
  • U.S. Food and Drug Administration (FDA) Regulatory Industry Forum
  • American Marketing Association
  • Society of Women Engineers
  • Certified International Quality Auditor (CIQA) - Quality Documentation Specialist Certification
  • Document Control Systems International (DCSI)
  • American Society of Safety Professionals
  • Project Management Institute (PMI) – Document Control Special Interest Group
  • Global Regulatory Documentation Association
  • American Medical Informatics Association

Certifications

  • Certified Information Professional (CIP) by AIIM
  • FDA Quality System Regulation (QSR) Certification
  • CompTIA Security+
  • ISO 14971 Risk Management for Medical Devices Certification
  • Good Documentation Practice (GDP) Certification
  • Certified Quality Engineer (CQE) by the American Society for Quality (ASQ)
  • Certified Regulatory Affairs Professional (RAC) by the Regulatory Affairs Professionals Society (RAPS)
  • Medical Device Single Audit Program (MDSAP) Certification
  • Project Management Professional (PMP)
  • Six Sigma Green Belt Certification

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