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.
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.