Quality Director
Cryo-Save
Total years of experience :19 years, 2 Months
• Responsible for all technical aspects of the facility related to the provision of cord blood unit products, tissue, and related services
• Hire, supervise, and train staff in all aspects of processing, analytical work, regular instrument operation, maintenance and calibration
• Conduct quality management reviews and improvement meetings
• Write, revise, and approve SOPs, policies, processes and procedures to be followed in the
• Anticipate sample release problems and takes corrective action, escalating as needed, to resolve and achieve commitments
• Implement ongoing quality improvement processes, Evaluates Corrective Action/Preventative Action (CAPA) effectiveness and prepare root cause analysis
• Develop and analyze statistical data to establish quality programs and measurements to improve operations, participate in the resolution of quality issues in a timely manner; ensure value stream process and system adherence to approved procedures.
• Check the quality control results of each batch of tests and keep a record of all problems and remedial action taken in co-operation with the quality system.
• Review all the sample results, including CBCs, MNC, TNC, viability and CD34 cell count
• Supervise a complete stock check of all reagent and consumable requirements in the laboratory by the senior technologist on a weekly basis, co-ordinate with the Material Suppliers for requirements and promptly inform needs for consumables and problems associated with supplies
• Sets up and maintain the Laboratory Database System
• Prepare and notify the change control, deviation or non-conformance report after root cause analysis.
• Conduct internal and external audits
• Auditor and Member of American Association of blood banks (AABB)
• Member of American Society of Quality(ASQ)
• Experience in Quality Management ISO 9001:2000
Memeber of National Association of Health Care Quality(NAHQ)
• Responsible for conducting research, development and manufacturing laboratory experimentation and other scientific activities to support Ventana projects throughout the organization
• Design bench experimental protocols
• Prepare technical reports, summaries and quantitative analysis for presentation to management
• Maintain complete and accurate data in compliance with GMP and GLP policies and procedures
• Monitor work to ensure quality and continuously promote quality first time
• Present and discuss results of experiments within departments and project teams
• Interact with vendors, research, and purchase laboratory equipment
• Investigating and troubleshooting equipment and develop solutions for correction
Perform quality measurements/assessments necessary to maintain regulatory compliance
Responsible for ensuring conformance to in-house specification and adherence to cGMP and GLP
Validate processing and testing methodologies while working to constantly improve processes
Compile data for documentation of test procedures and report; offer suggestions for abnormalities
Maintain quality records, forms, work orders and assist in internal and external audit preparations
Analyze existing quality techniques and developing new/revised techniques, instructions, and SOP's
- Special Projects -
Developed new Environmental Monitoring standards and procedures to comply with FDA and AABB regulations
Developed new process for measuring sample temperatures; tested and implemented, increasing accuracy by 12%
Graduated with Honors, MS, Biotechnology (2009) Graduated Valedictorian and Magna Cum Laude with special honors in Genetics. (2003) Succesfully completed Communication and Managment leadership training at CBR. (2006) Completed Geneomics and infectious disease, use of laboratory animals in research, emerging infectious diseases and medical terminology and abbreviations certificates as continuing education. (2006-7) Completed general lab safety and blood born pathogens training at the University of Arizona. (2005) Prepared a dispense chart to help easily recognize the number of tubes needed based on the volume of samples. (2006) Developed a procedure for dispensing small-volume samples from collection bags in order to maximize the amount of blood recovered. (2007) Extensive use and experience with Microsoft word, Excel, Data log, Power point, Visio, and Outlook.