To obtain a position in a progressive organization where I can utilize my skills and experience to improve the company's productivity and reputation for the company.
management, change control, engineering, audits, quality, medical devices, analysis, risk management, validation, fda, maintenance, medical, iso
capa, management, administration, retention, coordinator, access, metrics, training, quality, process improvement, records management, audit, collection
Assisted with ISO 9001:2008, ISO, cGMP, quality assurance, and audits. Provided support for the development and implementation of the QMS.
Managed the development and implementation of the manufacturing and quality control system for the laboratory. Developed and implemented the management and validation protocols for the ISO 9000.
Conducted safety inspections, risk assessment, and engineering analysis. Implemented corrective actions to ensure the compliance with medical devices.
Assisted in the development and maintenance of all ISO 9000 documentation for the analytical process. Conducted monthly QA/QC audits.
Participated in the development and revision of new methods for the transfer of analytical methods to the audit team. Developed and implemented the training and documentation of the test methodologies.
Quality Assurance Specialist
Talecris Plasma Resources
Coordinated with the quality management group to ensure that the laboratory was in compliance with the QMS, the company, and the National budget.
Created and implemented quality assurance program for the QMS, including the development of the QA/QC management system, and the audits of the data collection tools.
Conducted monthly audits of the quality management system (QMS) and provided training to the HR department on the development of the QMS, compliance, and certification.
Managed quality management system for the QMS, including training, development, and reporting of all customer complaints. Implemented corrective actions and corrective action plans.
Performed internal audits, supplier quality audit, and supplier quality management audits. Developed and implemented corrective actions, CAPA, and risk management plans.
Managed the quality control audit team, including the development of the QMS, training, and compliance management. Conducted audits and internal auditing.