Quality Assurance Manager

EXPERIENCE:

SYSTEM SUPERVISOR, BLOOD BANK

(December 19, 2011–Present)

Duties: Responsible for management of the blood banks and apheresis program for the health care system. Responsibilities include ensuring an adequate blood inventory is available, managing the budgets for the blood supply, operations, capital equipment and personnel. Responsible for preparing staff schedules, staff evaluations, performance improvement plans and salary determinations for personnel. Responsible for coordinating the consolidation to system wide policies/procedures for the blood banks and apheresis programs. Responsible for the ensuring the departments are in compliance with AABB, CAP, FDA agencies standards, rules and regulations.

Geisinger Health System

100 North Academy Drive

Danville, PA 17822

QUALITY ASSURANCE LEAD, TRANSFUSION SERVICES: (September 19, 2005-December 16, 2011)

Duties: Responsible for quality assurance functions within the Transfusion Services to include: Monitoring, tracking, trending and reporting of adverse events, corrective actions and assisting the Risk Management Department with reporting of blood product deviations to the FDA. Maintaining records of Blood Supplier market withdrawals, look-backs and recalls, supervise the equipment management program, implement and maintain the document and change control processes, ensure cGMP practices are in place and followed. In addition, manage the personnel proficiency program including interacting with CAP, ensure compliance in the Transfusion Service with relevant regulatory agencies and for facilitating inspectons and assessments by external agencies. Attend various intradepartmental meetings regarding blood product wastage and unacceptable specimens as the Transfusion Services representative. Assist the Manager, Transfusion Service with a variety of projects and validate processes within the Transfusion Service. Member of the institutional Transfusion Committee where I present various quality improvement data on a quarterly basis. Member of the institutional FMEA Risk Analysis Committee for reviewing transfusion process. Member of the Clinical Laboratories Quality Improvement Committee.

The Ohio State University Medical Center

Transfusion Services

410 Tenth Avenue

Columbus, Ohio 43210

MANAGER, PLACENTA PROCESSING LABORATORY: (January 5, 2004-September 8, 2005)

Duties: Responsible for operation of the Placenta Processing Laboratory to include: Staffing; development of job descriptions, implement training schedules and competencies, responsible for hiring, disciplinary actions and review processes. Product Development; member of the task force that was responsible for suggesting new ideas for improvement of processes. This involved recommending new methodologies, writing protocols, implementing the protocols, documentation of data collected during processing, preparation of and presentation of data to executive management and making recommendations for additional process improvements. Budget: Responsible for monitoring budget process and ensuring operations occur within the budgeted monies. Operations: Managed daily processing, procedure development, implementation and document control, equipment purchasing and maintenance program, validation procedures for equipment and processes and equipment monitoring system.

Celgene Corporation

45 Horse Hill Road

Cedar Knolls, NJ 07029

MANAGER, BLOOD DONOR PROGRAM/QUALITY ASSURANCE OFFICER: (June 4, 2001-January 1, 2004)

Duties: Responsible for oversight of the Blood Donor Program that supplied 90% of the medical center’s blood product needs to include; recruitment of donors and donor recognition, suitability of autologous, allogeneic and directed donors, collection of donor blood, preparation of components. Managed staff responsible for above functions, developed job descriptions, interviewed and recommended for hire potential new employees and ensured all staff training and competency had been performed. Developed new procedures and all relevant validation protocols including validation protocols for new equipment. Ensured that all quality control and equipment maintenance had been performed, as required. Responsible for the Quality Assurance Plan for Transfusion Services and ensuring cGMP were in place and followed. Responsible for ensuring compliance in all areas above with relevant regulatory agencies and for facilitating inspections and assessments by external agencies. Developed and assigned self-assessments for the Blood Donor Program and the Blood Bank. Performed investigation of all deviation/non-conformance reports, tracking and trending of reports, ensuring corrective actions were appropriate and working and submitted appropriate reports to the FDA and New Jersey State Department.

Somerset Medical Center

110 Rehill Avenue

Somerville, NJ 08876

MANAGER, CELLULAR THERAPIES: (March 1, 2001-May 30, 2001)

Duties: Interim manager of the Cellular Therapies section of the Gene Transduction Laboratory. Responsible for performing tissue cultures, gene transduction protocols, colony forming assays and developing protocols for cellular selections. Responsible for ordering supplies, quarantining and releasing them after suitability was established. Developed protocols for validation and use of equipment used in the cellular protocols. Ensured that protocols complied with all regulatory requirements.

Memorial Sloan-Kettering Cancer Center

1275 York Avenue

New York, NY 10021

DIRECTOR, CORD BLOOD AND COLLECTION LABORATORIES: (June 5, 2000 – January 14, 2001)

Duties: Developed protocols to establish a cord blood bank for hematopoietic progenitor cell collection and processing. Recommended the appropriate protocols to be used for the processes, wrote procedures for the quality assurance, safety, training and the collection, processing and distribution methods. Reviewed the regulatory requirements for the operations and prepared recommendations on how to meet the requirements. Developed job descriptions for various positions within the operations of the laboratory. Developed the budget for collection and processing of the cord bloods based on 25,000 collections in the first year. Made recommendations regarding capital and non-capital equipment.

UltraGen, Inc.

Glenpointe Centre East

300 Frank W. Burr Blvd.

Teaneck, NJ 07666

QUALITY ASSURANCE SPECIALIST: (October 11, 1999 – June 2000)

Duties: Responsible for developing multiple system processes for the Cellular Therapy Laboratory, including developing and revising processing, cryopreservation and infusion procedures for a GMP laboratory. Establishing regular equipment maintenance policies and instituting and revising quality control procedures. Refining the training program and establishing the continuing education policy. Responsible for implementing the Quality Assurance plan and helping the Manager of the operations side of the laboratory to implement the necessary procedures to comply with the Quality Assurance plan.

Progenitor Cell Therapy, L.L.C.

20 Prospect Avenue, Suite 400

Hackensack, New Jersey 07601

SUPERVISOR: (March 1997 – June 2000)

Duties: Responsible for establishing the Cellular Therapy Laboratory, including developing processing, cryopreservation and infusion procedures, validating all procedures, setting up new equipment establishing quality control and maintenance procedures, developing and implementing a Quality Assurance program and setting up billing codes and prices. Coordination of product sample testing with the supervisor's of the Blood Center responsible for product collection, the Central Processing Laboratory, the Blood Bank, the Hematology, the Flow and the Microbiology Laboratories. Responsible for coordinating with Blood Center staff to develop the procedures for reporting product infectious disease testing results. Oversight of the construction of the new laboratory, coordinating equipment purchase and delivery and validation of new laboratory equipment. Validated the Datatron Remote Monitoring System. Prepared the budget for the laboratory. Developed the training and competency programs for the laboratory and training new employees and students, including lectures, preparing examinations, and teaching bench procedures. Responsible for interviewing and hiring new employees and revising job descriptions, as necessary. Performed work performance appraisals and developed action plans for employees, when required. Provided orientation for the Stem Cell Transplant nurses and other hospital staff, when requested.

Saint Barnabas Medical Center

94 Old Short Hills Road

Livingston, New Jersey 07039

SUPERVISOR (November 1993 - February 1997)

Duties: Responsible for establishing the Stem Cell and Cryopreservation Laboratory, including developing processing, cryopreservation and infusion procedures, validating all procedures, setting up new equipment, establishing quality control and maintenance procedures and setting up billing codes and prices. Coordinated sample processing and testing with the supervisor's of the Blood Donor Room, the Central Processing Laboratory, the Blood Bank, the Hematology, the Hematopathology and the Microbiology Laboratories. Coordinated with the Medical Center of Central Massachusetts staff to develop the procedures for our laboratory to cryopreserve their peripheral blood progenitor cell products. Responsible for helping to establish the Cord Blood Program for The American Cord Blood Program at the University of Massachusetts Medical Center, including helping to develop the budget developing and implementing; the processing procedures. Maintained records, helped to instruct hospital staff regarding collection and processing techniques and in ensuring regulatory guidelines were met Responsible for overseeing the construction of the new laboratory and coordinating the move into the new laboratory. Prepared the budget for the laboratory and the capital equipment budget, Developed the training and competency programs and the Quality Assurance program for the laboratory. Trained new employees and students, including lectures, preparing examinations, and teaching bench procedures. Responsible for interviewing and hiring new employees. Revised job descriptions as necessary, performed work performance appraisals and developed action plans for employees, when required.

University of Massachusetts Medical Center

55 Lake Avenue North

Worcester, Massachusetts 01655

ASSISTANT COMPLIANCE OFFICER: (December 1992 - November 1993)

Duties: Responsible for maintaining and updating MSDS files. Prepared samples, compiled and maintained records for employee accidental exposure to blood borne pathogen incidents. Reviewed non-reportable errors and reviewed and submitted reportable errors to National Red Cross in the absence of the Compliance Officer. Assisted with developing, implementing and reviewing Standard Operating Procedures. Performed internal audits to ensure compliance with regulatory agencies. Assisted in reviewing corrective action plans from departments that were prepared in response to citations from regulatory agencies. Re-inspected the departments after the implementation dates of their corrective actions to ensure that the blood center had achieved compliance with regulations. Assisted with external inspections i.e., CLIA, FDA, AABB and National Red Cross. Assisted with correspondence to different regulatory agencies as necessary to achieve compliance with regulations. Performed National Red Cross inspection of other Red Cross Blood Services as needed.

SUPERVISOR: (August 1985 - December 1992)

Duties: Responsible for supervising HLA Laboratory with a staff of six-medical technologists and technicians. Organized the laboratory workflow where tests for HLA-ABC and DR phenotyping, HLA antibody screening, and platelet testing were performed. Responsible for developing new procedures and reviewing all procedures, as necessary. Responsible for seeing that staff conformed to regulatory standards. Provided assistance in preparing the budget for the laboratory, and preparing the capitol equipment budget. Trained new employees and SBB students, including lectures, presenting slide presentations, preparing examinations and teaching bench procedures. Responsible for interviewing and hiring new employees. Revised job descriptions, as-necessary. Performed work performance appraisals and developed action plans for employees who where not performing satisfactorily. Provided consultation and educational services to regional hospitals, medical technologists, and physicians.

American Red Cross Blood Services, Northern Ohio Region

3747 Euclid Avenue

Cleveland, Ohio 44115

EDUCATION:

SPECIALIST IN BLOOD BANKING B.S IN BIOLOGICAL SCIENCES

American Red Cross Blood Services, Northern Ohio Region Cleveland State University

3747 Euclid Avenue Euclid Ave. at East 24th St.

Cleveland, Ohio 44115 Cleveland, Ohio 44115

ORGAN1ZATIONS: AABB, ISCT

CERTIFICATIONS: MT, SBB(ASCP)

ADDITIONAL ACTIVITIES Perfo

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