COVER LETTER: To whom it may concern The employment vacancy imparted the idea that the workplace is fast paced and innovative in it's approach to laboratory testing. I am looking forward to working with a company that is able to evolve with the changing medical industry as well as stay competitive and become a leader in the forefront of emerging pharmaceutical technologies. I eagerly anticipate to gain further experience and knowledge in the pharmaceutical field as well as impart the knowledge I have with ISO 13485, 820,821 15189, so as to be of greater service for the company that I am employed with. I have 20 years of experience in the clinical laboratory science and quality regulatory field and have held supervisory and managerial positions. I am ASCP certified as a clinical laboratory scientist and continue to manage the certification as I am deeply involved with the laboratory production to make sure that the laboratory remains compliant. I have worked and trained in the areas of microbiology, immunology, serology, virology, cytogenetics, viral polymerase chain reaction testing, flow cytometry, clinical chemistry, blood bank medicine, applied chemistry, urinalysis, and hematology including hemostatic evaluation. I have a generalist training and am able to work competently in all the above mentioned sub fields including the quality assurance and regulatory component. Thank you for your time in considering my application. For further questions please email me at laurensayavedra@yahoo.com (usually the best way to contact me) or call me at 210-237-3092. OBJECTIVE: & Strategy: The quality system's lead provides oversight and leadership to the Pharma & Clinical Division laboratory operations ensuring adherence to and driving improvements to the Quality Management systems (QMS). Compliance: Ensures continual assessment of QMS data and on-going operations to ensure appropriate execution to company policies and procedures and regulatory requirements per CAP/CLIA, NY State, ISO 15189/13485, FDA 21CFR820. Customer focus: Partner with external and internal customers to ensure resolution and communication of quality issues, data streams are provided, internalized and acted upon to ensure world-class quality performance. External Audits: Responsible for supporting the external and internal auditing activities and plans, and representing the quality operations to the auditor. Non-Conformance Management: Responsible for supporting the organization with root-cause analysis, corrective/preventive effectiveness checks verification and validation to execute complex CAPAs. Timely completion and follow up through to closure of CAPA actions. Provide the team with guidance on how to gather investigations within Non-Conformance Management System. Process Improvement: The quality system's lead partners with Pharma & Clinical Division functional leaders to identify key quality performance projects and implement systemic improvements and standards that will reduce customer complaints, non-conformances, compliance with Quality, business requirements, and improve quality performance. Actively participate and/or drives US/EU/Global QMS improvements as required. Quality Metrics: Measuring and monitoring of performance against agreed KPIs. Collate and share information / data across the site as appropriate through reports and follows up on identified improvement opportunities. Support reporting of key related metrics on quality risks, issues, initiatives, and projects at cross-functional meetings and shares new and or/revisions to regulatory requirements as defined by NeoGenomics Quality Management Director and the leadership team. Supplier Quality: Supplier status (state of compliance, contact information, approved parts/components/materials, etc.) Management of approvals at the individual part or service level Ongoing quality metric surveillance (of NCMRs, CAPAs, deviations, inspection data, audits, etc.) Analytics and reporting of supplier data (with filtering and trending capabilities) Access to AVLs (enterprise-wide, in real time) Integration with other quality processes (CAPA, audit, deviation, risk, etc.) Achivements: Established Supplier Quality Compliance Program and Operational Metric Program to ensure continuous laboratory monitoring throughout the organization under CAP, CLIA and ISO15189 standards. November 2010 to 2015 -Quality System's supervisor - FISH department 2014 - 2015 and FISH Supervisor 2010 - 2014 Neogenomics Inc is located in Irvine, California. It is a reference oncology testing laboratory with specialties in Molecular genetics, Cytogenetics, and Flourescent Insitu Hybridization -The responsibility of the Quality system supervisor is to define, coordinate, and monitor quality assurance programs for the laboratory to ensure that quality procedures are followed and are up to date and compliant. The supervisor also plans and oversee's internal inspections -The responsibility of the FISH supervisor is to oversee the planning, coordination, evaluation and supervision of all technical and operational activities and staff members in the laboratory. The supervisor also coordinates R&D activities as they relate to the laboratory, develops a budget and manages department cost and resources that adhere to the budget.

Highlights:

• Neurological
• Nursing
• Phlebotomy
• Physical Therapy
• Rehabilitation
• Satellite
• Therapy
• Transcribing
• Instrumentation
• Quality