Lead a team of 6 coordinators and 1 quality specialist. The team coordinates special products and services including autologous and directed donations, therapeutic phlebotomy, HLA matched platelets, and cellular therapy collections. Provide quality support including writing SOPs, providing training, writing validation plans, and participating in audits.

• Wrote, revised and reviewed department quality system documents.• Created, edited and summarized validation plans. • Knowledge of cGMP (current Good Manufacturing Practice), cGTP (current Good Tissue Practice) and CQI (Continuous Quality Improvement)• Ensured the department was in compliance with regulatory/accrediting agencies including FDA, AABB (American Association of Blood Banks), FACT (Foundation for the Accreditation of Cellular Therapy) and NMDP (National Marrow Donor Program). • Investigated and documented all non-conforming events for the department.• Performed root cause analysis. Assigned and followed-up on corrective/preventative actions.• Assisted in retraining as a result of incident management analysis.• Created training materials, and assisted with training and assessing staff.• Participated in LEAN events to help identify solutions or efficiencies and to ensure all standards and regulations are followed.• Collected, analyzed, and monitored metrics related to the quality functions and process improvement. • Generated Quality Indicator Reports for hospital customers. • Reported out quarterly to internal quality executive team. • Participated in internal and external audits of the department. Wrote responses in consultation with department management.• Responsible for patient chart audits and managing equipment quality records including preventive maintenance and repairs.• Participated as a charter team member for the evaluation of a new company-wide document management system.• Helped facilitate the Request for Purchasing for a vendor for new scheduling software for the department. Configured the software, trained staff and implemented the go-live.• Thorough understanding of donor qualification and suitability for autologous and allogeneic product collection.• Continuous Improvement focus

• Responsible for daily billing, data entry, inventory management and patient scheduling. Supported department manager and nurses.• Lead scheduler and trainer for autologous, directed and therapeutic donor functions in the department.• Generated daily reports for BloodCenter physicians to efficiently communicate patient information.• Assisted with executing validation plans of new or upgraded systems. • Reviewed and revised quality system documents to ensure accuracy. • Participated in 5S Kaizan for the Therapeutic Services supply room which resulted in reduced inventory and made more efficient use of space.• Contributed to a team work-out to define parameters for a new purchasing system.• Developed a department specific value stream map for the autologous donation process. Presented the results to the executive team.• Generated queries in Access to provide patient information to BloodCenter physicians.• Coordinated patient schedule for all therapeutic apheresis procedures. • Attended various LEAN events that focused on creating efficiencies in the department.

• Triaged and scheduled autologous, directed and therapeutic donors with a high degree of accuracy and efficiency, while providing excellent customer service.• Assisted in training new employees.• Participated in quality assurance and process improvement activities.• Assisted with daily billing.

• Key support in sales and customer service to a major customer for six years.• Accomplished the goal of a long-term contract renewal.• Responsibilities included finding new opportunities for growth, finding cost-savings opportunities for the customer, and implementing new products and programs.• Supervised an inside customer service person and trained all new employees. • Maintained accurate logs, including certificates of analysis, as required by the FDA.• Responsible for daily billing and inventory management.

• Responsibilities included taking and entering orders, dispatching drivers, writing quotes, inventory control, and invoicing.