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.
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.
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.