Roger Austin - Project Lead Resume Simple
SUMMARY
A highly motivated, detail-oriented, and results-driven professional with over 15 years of experience in the pharmaceutical industry. Proven ability to manage multiple projects and meet deadlines.
SKILLS
  • management, capa, iv, documentation, assessment, inspection, compliance, quality, audit, sops, monitoring, metrics, evaluations, project management, team management, process improvement, collaboration
  • quality control, implementation, administrative, operations, research, quality
WORK EXPERIENCES
  • 2017-12-252017-12-25

    Project Lead

    Zoll Medical Corporation

    • Performed project management, risk assessment, and risk mitigation planning, including the development of regulatory documents, and the procurement of study related documents.
    • Provided support to the project team, including the development of monitoring plans, risk mitigation and corrective actions, and environmental monitoring and regulatory compliance.
    • Developed and implemented a system for the process improvement project, including the development of the QMS, risk assessment, and product development.
    • Developed and implemented corrective actions, including quality assurance, QA, and audits. Managed the documentation process. Identified and resolved issues.
    • Served as the lead CRA for the project team, including the development of monitoring plans, and metrics for the implementation of investigations.
    • Performed gap analysis of the site evaluations and audits of the laboratory operations department. Implemented and maintained the QMS system, including the creation of a new SOP.
  • 2017-12-252017-12-25

    Quality Control Manager

    The University of Tennessee

    • Conducted quality assurance and research operations for the implementation of new and existing processes. Managed and maintained all aspects of the study.
    • Conducted administrative and technical support for the entire department, including training of new employees, developing and implementing standard operating procedures (SOPs).
    • Provided training to new employees on the use of standard laboratory procedures. Assisted in the development of test methods and procedures.
    • Reviewed and approved all quality control documents for the raw material and finished product specification. Review and approve batch records and final release forms.
    • Managed the development of the project Master file (TMF) for the Division of the US and Canada. The responsibilities included: The creation of a comprehensive document control Plan, and the implementation of the quality assurance
    • Maintained quality control records for all data and submitted to the regulatory authorities. Assisted in the preparation of reports for submission to the IRB.

 Education America Network 

 Quavera alliance