• Developed monthly, end-of-quarter, and other statistical reports for leadership team and quality improvement programs.• Implemented use of Power BI to illustrate KPIs to the quality group• Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.• Lead Practical Process Improvement (PPI) events to address issues to increase productivity and boost workflows.• Completed deviations, CAPA, and investigations and recorded findings in our QMS.

• Responsible for leading the Quality Control department in product testing, investigations, maintaining the database, and auditing.• Created and achieved product quality objectives and met product specifications.• Created Quality Control standard operating procedures (SOP) and work instructions (WI) to meet compliance requirements.• Trained existing and new employees on multiple investigative case types and internal control processes.• Lead projects to create KPI dashboards, quality control tests, audits, and creating specifications for processes.• Completed bioburden tests under tight deadlines to meet client demands and project timelines.

• Tested Bio-Rad’s products for bioburden to ensure the quality of the product.• Perform growth promotion testing on biological media.• Collected and analyzed biological data about relationships between organisms and the environment.• Adhered to ISO 13485 and GxP standards while performing to task • Conducted investigations using root cause analysis (RCA) tools• Initiated Corrective and Preventative Action (CAPA) when nonconformances occur.• Ensure the effectiveness of the CAPA by monitoring it in our QMS • Perform Environmental Monitoring testing for multiple Bio-Rad facilities; testing the air for TAP and VAP

• Conducted environmental monitoring testing of the facility• Reviewed batch records for GDP• Test the raw materials and finished products to ensure the quality and safety• Performed environmental monitoring of the production area to ensure a proper work environment.