• Responsible for oversight of Sr. Quality Specialist team with regard to Quality Management System inclusive of deviations, Root Cause Investigations, Corrective/Preventative actions and CAPA effectiveness.• Provided Quality Assurance support and guidance to Product Development programs with respect to Design Control documentation, Risk Management, and Verification & Validation activities.• Championed the Change Control system in relation to equipment qualification, process validation, risk mitigation and design transfer initiatives.• Managed ten (10) employees in the Biological Quality Assurance department responsible for executing towards the Environmental Monitoring program and performing both in-process raw material and final product testing for microbial growth. • Offered support with review of Supplier corrective action reports associated with material non-conformances and performed supplier audits as needed.• Reviewed document revisions for accuracy and impact to overall manufacturing process to ensure all requirements are met prior to implementation.• Participated in the execution of Internal Audits and led initiatives of continuous improvement to support external audit readiness.• Assessed confirmed customer complaints as a member of the Product Complaint Review Board to determine Field Action requirements to meet both Quality system and Regulatory requirements.• Maintained Quality System Scorecard Metrics and identified trends in nonconformance, department escapes, investigation timeliness/effectiveness

Developed Quality Management System and process validation for the manufacture of Stem Cell productsPerformed Equipment Qualifications on Laboratory Equipment

Performed final quality assurance review of product release and quality documentation of all products manufactured, assembled & distributed by the facility.Maintained product complaint system through research of complaints, development of corrective actions and communicated corrective action responses to customers.Conducted training for GMP, Safety, blood-borne pathogen and developed other training programs in collaboration with Kaizen Events and Lean Six Sigma Projects.Performed monthly quality system audits and generated audit reports, developed CAPA plans and other action items required for compliance within the quality system.

Managed preparation and production of blood components in accordance with regulatory rules and standards.Established, monitored, and evaluated center-wide Quality Improvement activities for the department.Developed and monitored annual departmental budget.Identified, purchased and validated equipment for adequate laboratory operationsConducted performance management appraisals on each employee

Managed all aspects of Quality and Administrative functions associated with the Hospital Services DepartmentPerformed quarterly customer service visits and evaluated customer service survey results to identify areas of improvementConducted thorough audits on blood product storage equipment and temperature documentationDeveloped and distributed marketing materials to prospective clientsServed as lead employee on the Unit Disposition Committee to ensure all daily unit disposition was properly completed & reviewed.Implemented & managed web-based Inventory Management Software

Negotiated & executed contracts with both current and prospective clientsFormulated educational materials and delivered in-services for clients to ensure compliance of FDA and AABB blood bank standardsConducted client audits on blood product storage equipment Performed Donor antigen screening, ABO/Rh testing, and antibody identification for cross-match clients in a Reference laboratory setting