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Skills

  • First Aid/CPR
  • Cross-border audit coordination
  • Conflict resolution in a professional environment
  • Compliance with environmental, health, and safety (EHS) regulations
  • Audit report writing and documentation
  • Team management
  • Regulatory compliance
  • Corrective and Preventive Actions (CAPA)
  • Internal audit program management
  • Cross-functional team collaboration

Work Experiences

  • Achieved certification on the first audit cycle.
  • Aligned quality audits with design specifications.
  • Reviewed and resolved issues that arose during the release of APIs, Safety Assessments, or clinical supply lots for regulatory compliance.
  • Was in charge of checking departmental forms for adherence to submission rules and guidelines.
  • Interpreted test results by comparing them to established specifications and control limits, and then made recommendations about whether or not the data should be released.
  • Trained junior employees on departmental responsibilities and reviewed their work.
  • Followed safety and clean-up procedures to comply with agency and regulatory mandates.
  • Technical documents such as deviation reports, testing protocols, and trend analyses were all written by me.
  • Documented and executed detailed test plans and test cases, as well as summarized and logged audit findings for reporting purposes.
  • Conducted a data review and followed standard procedures to find solutions.

Summaries

  • Adept at conducting thorough non-conformance investigations.
  • Achieved a 43% reduction in waste.
  • Overall morale and productivity are boosted by experience in policy development and staff management procedures.
  • Quality Systems Auditor with 17 years of successful stakeholder engagement and workflow optimization experience.
  • Extensive testing of incoming materials, components, and finished products is second nature to me.
  • In metric environments, a hardworking Quality Systems Auditor who is knowledgeable about sampling and testing procedures.
  • Accomplished in spearheading a continuous improvement tracking tool that improved audit consistency and earned Employee of the Year for excellence in operational outcomes.
  • Quality Systems Auditor is a multi-talented Quality Systems Auditor who is consistently rewarded for planning and operational improvements.
  • Strong experience collecting and analyzing quality metrics as well as making recommendations for process and quality improvement.
  • Accomplished industry professional.

Accomplishments

  • Led the implementation of a new quality monitoring software, improving audit traceability by 65% and enhancing regulatory compliance.
  • Audited operational processes and identified 17 critical areas for improvement, leading to a 18% increase in compliance with regulatory standards.
  • Led compliance programs across 15 locations, increasing compliance to quality and safety protocols by 76%.
  • Resolved product issue through consumer testing.
  • Initiated a root cause analysis effort for recurring non-conformances, leading to a 81% reduction in similar future events.
  • Reviewed and updated internal quality control documentation, resulting in 13 fewer observations during external audits.
  • Standardized documentation for quality audits across multiple teams, improving the feedback loop and reducing processing time by 31%.
  • Successfully executed corrective action follow-ups, closing 6 non-compliance reports and achieving 52% compliance in 2017.
  • Conducted 13 internal audits, ensuring full compliance with ISO CPA and reducing audit findings by 39%.
  • Developed risk-based audit schedules, leading to 34% reduction in non-conformances during regulatory inspections.

Affiliations

  • American Society of Safety Professionals
  • Lean Six Sigma Black Belt, Association for Manufacturing Excellence (AME)
  • Association for Supply Chain Management (APICS)
  • Rotary International
  • American Medical Informatics Association
  • International Organization for Standardization (ISO) Technical Committee Member for Quality Standards
  • Association of Information Technology Professionals
  • International Association of Administrative Professionals
  • Member, ASQ Risk and Compliance Division
  • Risk Management Professionals Association (RMPA) - Member since 2017

Certifications

  • Certified Quality Auditor (CQA) – system
  • Failure Mode and Effects Analysis (FMEA) Certification
  • Microsoft Certified Systems Engineer (MCSE)
  • Certified Value Improvement (CVI) Professional
  • Certified Internal Auditor (CIA)
  • Supplier Quality Professional (SQP) Certification
  • Good Manufacturing Practices (GMP) for Quality Auditors Certification
  • Apple Certified Associate (ACA)
  • ISO/TS 16949 Internal Auditor Certification
  • Certified Hazard Analysis and Critical Control Points (HACCP) Auditor

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