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Quality Systems Auditor resume examples

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Skills

  • Conflict resolution in a professional environment
  • Corrective and Preventive Actions (CAPA)
  • First Aid/CPR
  • Supervision
  • Sampling protocols
  • Time management and prioritization
  • Operations monitoring
  • Project organization
  • Relationship development
  • Audit finding root cause determination

Work Experiences

  • Achieved results in the past year.
  • Provided project updates and consultation as a liaison between quality control and other departments and contractors.
  • Performed cell-based potency and impurity assays for in-process, release, and stability samples.
  • Developed and audited practices, programs, and reporting system metrics for maximum efficiency.
  • 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.
  • Aligned quality audits with design specifications.
  • Achieved results over a 6 months.
  • Conducted a visual inspection of products to determine if they met quality standards.
  • Achieved compliance with customer audits.
  • Achieved a 73% improvement in audit visibility.

Summaries

  • Accomplished in overseeing global supplier compliance, reducing out-of-compliance issues by 46% through external audits and alignment to best practices.
  • To conduct experiments successfully, pays close attention to detail and uses critical reasoning.
  • In metric environments, a hardworking Quality Systems Auditor who is knowledgeable about sampling and testing procedures.
  • Achieved a 79% reduction in operational waste.
  • Skilled auditor who collaborates effectively with peers, management, and external authorities at all levels.
  • Extensive testing of incoming materials, components, and finished products is second nature to me.
  • Recognized for motivating management team members to achieve their goals and fostering innovative work environments.
  • Ready to put 10 years of experience to work in order to meet initiative quality control goals.
  • Aligned audits with product design specifications.
  • Within Manufacturing and Production, senior Quality Systems Auditor and outstanding performer in client relations and workflow optimization.

Accomplishments

  • Successfully executed corrective action follow-ups, closing 6 non-compliance reports and achieving 52% compliance in 2017.
  • Used Microsoft Excel to develop inventory tracking spreadsheets.
  • Implemented a supplier quality improvement initiative that raised first-pass yield from 60% to 65% in one year.
  • Reviewed and updated internal quality control documentation, resulting in 13 fewer observations during external audits.
  • Designed a risk-based auditing program that identified and mitigated 7 potential business risks, preventing a significant compliance lapse.
  • Performed thorough review of calibration records, cutting equipment downtime by 50% and saving the company $6 annually.
  • Developed risk-based audit schedules, leading to 34% reduction in non-conformances during regulatory inspections.
  • Reviewed and updated the company’s quality assurance protocol, leading to 39% reduction in audit non-conformances.
  • Facilitated management reviews of the quality management system, driving adherence to KPIs and achieving 57% improvement in site operations.
  • Led continuous improvement projects to address systemic non-conformances, reducing incident reports by 21% across 5 sites.

Affiliations

  • Society of Women Engineers
  • Project Management Institute (PMI) - PMP Certified Auditor
  • Certified GMP (Good Manufacturing Practices) Auditor, ASQ
  • American Medical Informatics Association
  • Freemason
  • Institute for Supply Management (ISM) - Quality Standards Group
  • Member, ASQ Risk and Compliance Division
  • American Marketing Association
  • FDA Compliance & Regulatory Professional Network
  • Attendee, ASQ Audit Division Annual Conference Raleigh 2024

Certifications

  • SHRM Senior Certified Professional (SHRM-SCP)
  • Certified Manager of Quality/Organizational Excellence (CMQ/OE)
  • Advanced Product Quality Planning (APQP) Certification
  • Certified Professional for Quality Assurance (CPQA)
  • Certified Internal Auditor (CIA)
  • Certified Automotive Quality Lead Auditor
  • Certified Public Accountant
  • Certified Quality Auditor (CQA) – system
  • Certified Pharmaceutical GMP Professional - ASQ
  • Certified Lean Six Sigma Black Belt

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