Mary Lyell - Quality Assurance Analyst Resume Simple
SUMMARY
I am a highly motivated, detail-oriented, and results-driven professional with over 10 years of experience in the pharmaceutical industry.
SKILLS
  • management, analysis, manufacturing, audits, implementation
  • medical devices, communication, monitoring, compliance, distribution, fda, telephone, responsible, medical, clinical
WORK EXPERIENCES
  • 2017-12-252017-12-25

    Quality Assurance Analyst

    Computer Science Department

    • Lead project Manager for implementation of new processes and procedures. Ensured compliance with regulatory requirements. Developed and implemented QA/QC analysis.
    • Supported manufacturing operations and audits of the customer complaints. Provided technical support to the product development team. Reviewed and revised the final release of products.
    • Created and implemented a comprehensive management system for the project. The project was adopted by the US and Europe.
    • Developed and implemented a system to track and analyze data to ensure compliance with applicable regulations. Performed quality assurance reviews and provided feedback to the management.
  • 2017-12-252017-12-25

    Regulatory Affairs Coordinator

    Cornell University

    • Served as a liaison between the clinical trial sites and the FDA and the regulatory authorities. Assisted in the preparation of regulatory documents for the distribution of communication.
    • Responsible for the submission of regulatory documents to the medical Affairs department, including the following: The review of the informed consent process, and the development of the regulatory documentation for the content of the IND.
    • Ensured compliance with all regulatory requirements and federal regulations for the company. Reviewed and submitted regulatory documents to the FDA.
    • Coordinated with the investigational sites to ensure proper storage and shipment of clinical supplies. Performed monitoring of all SAEs and reported deviations to the IRB.
    • Ensured that all regulatory documents were up to date and followed. Provided technical advice to the client. I was also trained in the use of the new products.

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