Wendi Stotler - Senior Consultant Resume Simple
To obtain a position in the health care field that will allow me to utilize my skills and experience to provide quality patient care. I am a highly motivated individual with a strong background in the medical field.
  • management, sterilization, auditing, quality control, quality, quality assurance, testing, technical writing, writing, fda, microbiology, quality management, iso
  • sterilization, management, auditing, document management, documentation, change control, quality control, inspection, quality, quality assurance, testing, packaging, validation, fda, medical, iso
  • 2017-12-252017-12-25

    Senior Consultant

    Arch Health Partners

    • Development and validation of laboratory testing protocols for the validation of new products. Maintain compliance with FDA and other regulatory requirements.
    • Coordinated with the management and quality assurance team to ensure that all testing requirements are met. Conducted validation and troubleshooting.
    • Member of the Microbiology team, quality control and troubleshooting. Conducted root cause analysis and corrective action. Created and implemented corrective actions.
    • Writing and executing all QA/QC and validation protocols. Developed and implemented corrective action plans. Created and implemented internal audits.
    • Project lead for the development of new and existing processes and procedures. Developed and implemented corrective actions. Trained and mentored employees.
    • Develop and implement quality Assurance/quality control systems. Write and revise SOPs. Process validation. Review and audit.
  • 2017-12-252017-12-25

    Quality Assurance Specialist


    • Perform documentation of packaging and safety inspections for the FDA. Conduct and document inspection and release of raw materials.
    • Managed the validation of vendor documentation for auditing, release, and testing of raw material and finished goods. Ensured all laboratory and instrument calibration and quality control requirements were met.
    • Performed auditing of all product documentation and medical record review for distribution and release. Maintained records for auditing purposes.
    • Manage and maintain the quality control, QA, and documentation of all product lines, including the release of raw material, finished goods, and final products.
    • Review, approve, and maintain all documentation and records for the validation and release of the final product inspection.
    • Perform all internal audits, including but not limited to, data entry, document control, and reconciliation of product safety and manufacturing records.

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