Position Summary: We have an exciting opportunity to join our team as a Blood Bank Quality Analyst.
In this role, the successful candidate will be responsible for writing, updating and maintaining the Blood Bank Quality Assurance Plan and Self-Assessment (BBQAPSA) program. It affects all processes, products and people in the blood bank. The IQA, independent of Blood Bank line supervises, creates, maintains and measures the successful application of current Good Manufacturing Process (cGMP) in all blood bank sections using the Blood Bank Quality Assessment Plan and Self Assessment (BBQAPSA) program. The IQA conducts internal assessments, devises and schedules continuous system audits and process control checks, and reports the results of these to senior blood bank management, administration and hospital committees as required. The IQA represents the BB in external assessments such as FDA, NYS, AABB and CAP inspections.
Demonstrates mastery of Blood Bank Quality Assurance Plan Self Assessment (BBQAPSA) including the ten BB organizational standards known as Quality System Essentials based on the current AABB standards. Understands chain of command, including statutory responsibility of Executive Management, Medical Director, Administrative Director, Supervisory Structure, Quality system, Technical, Service and Staff positions. Is responsible drafting and maintaining with Medical director approval, covering all areas of blood banking including whole blood donation, aphaeresis donation including hematopoietic progenitor cell donation, component manufacture and related processes, donor testing, blood product storage, distribution, pre-transfusion compatibility testing, transfusion, adverse reactions to donation and transfusion.
Is fully competent to draft systematic Level 1 Policy Statements, Level 2 Process Descriptions, Level 3 Process Control Standard Operating Procedures, Level 4 Documents and Reports Management covering all areas of blood banking including whole blood donation, apheresis donation including hematopoietic progenitor cell donation, component manufacture and related processes, donor testing, blood product storage, distribution, pre-transfusion compatibility testing, transfusion, adverse reactions to donation and transfusion. Level 1 Policy Statements. Level 2 Process Descriptions. Level 3 Process Control Standard Operating Procedures. Level 4 Documents and Reports Management. Emergency Management Plan.
Is responsible for Validation procedures that establish recorded evidence that provide a high degree of assurance that specific process will consistently produce an outcome meeting its predetermined specifications and quality attributes, e.g. computer system, testing procedures, automated equipment Validation Plans. Understands that Policy and validated processes and procedures ensure the quality of the blood, components, tissue and services in the Blood Bank. Drafts and maintains policy, processes and procedure for all areas in the BB.
Coordinates program of analysis of Blood Bank (BB) Deviation, Non-conformance and Complications. Successfully tracks and trends product/service non-conformance and its possible consequences including: fatal donor and recipient transfusion reactions; transfusion reaction (TX RCT) detection and resolution; reporting, and evaluation of donor or recipient complications. Deviations, Nonconformance and Complications: drafts and maintains policies, process descriptions and procedures (SOP) to ensure the capture, assessment, investigation, and monitoring of deviations from meeting or failing to meet, specified requirements.
Prepares and presents for review to medical director, administrative director and Transfusion committee and Clinical Laboratory committee(s) reports on disposition of nonconforming blood, components tissue, derivatives, critical materials and service Quarantine, Retrieval, Deferral, Notification matrix for all NYU and outside source blood and components is to be maintained in sync with all applicable federal state and professional regulations and standards. Adverse events: transfusion and donor events shall be captured, assessed, investigated and monitored. Fatality Reporting: fatalities related to donation or blood transfusion or receipt of tissue (HPC) are properly reported internally and externally.
Internal/External Assessments. Isresponsible for coordinatingsystematic internal assessmentswithin BB sections, among BBsections and medical centerdepartments especially nursingand anesthesiology, and forcoordinating external assessmentsby federal, NYS and professionalregulatory groups. Devisescorrective action plans; preventiveaction plans, and quality monitoringactivities. Assessments: Internaland External creates and carriesout comprehensive schedule of allinternal system and processassessments, as required by thedepartment. Helps externalassessors to conduct inspectionsof blood bank activities, includingfederal, state, AABB, CAPProficiency Testing programs andinspections. Completes NYULMCrequired in-services, InfectionControl and Compliance.Completed annual healthassessment at OHS. Completesnecessary read and signdocuments for SOP updates in atimely manner.
Process Improvement: principal contributor to preparation of formal corrective and preventive action initiatives including documentation for occurrence, investigation of cause, determination of corrective action, and evaluation to ensure that corrective action taken and is effective. Quality Monitoring: data collection, analysis and suggestions for preventive action improvements. Understands documentation of facts, investigation of causes, and evaluation of corrections in occurrences. Consistently initiates preventive actions where immediate circumstances dictate as well as participates constructively in systematic process improvement.
Demonstrates knowledge of Facilities and Safety in Blood Banking including biological, chemical, radiation safety, and waste stream management. Complies with hospital and departmental standards. Facilities and Safety: drafts and maintains safety standards for personal work areas including bench, refrigerators, irradiator and stock rooms. Adheres to biological, and radiation safety standards and regulations. Always dispose of blood components in a manner that minimizes potential for human exposure to infectious agents.
Uses highly developed interpersonal skills to promote continuously improving quality in consultation with Medical and Administrative Directors of Blood Bank, Clinical Lab Leadership, Medical Center Quality Assurance Dept and Hospital Administration.
Maintain professional currency in the field of immunohematology, bloodbanking, stem cell and quality assurance by attending programs that provide aminimum of twelve CEU per year.
Performs other duties as assigned.
Minimum Qualifications: To qualify you must have a Minimum Qualifications:Bachelors degree, with certification in Quality Assurance and/or continuous extensive, high level blood bank management experience in transfusion/ HPC work experience with NYC 041 category technologist or supervisor licenses since 1994. MS Word, Excel, Access or other DB, graphing skills..
Required Licenses: Clinical Lab Technologist-NYS
Preferred Qualifications: Preferred Qualifications:Advanced graduate degree in QA or related health field. Familiar withHCLL. ASCP, BB, SBB or CQA credentials preferred.
Qualified candidates must be able to effectively communicate with all levels of the organization.
NYU Langone Health provides its staff with far more than just a place to work. Rather, we are an institution you can be proud of, an institution where you'll feel good about devoting your time and your talents.
NYU Langone Health is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sex, sexual orientation, transgender status, gender dysphoria, national origin, age, religion, disability, military and veteran status, marital or parental status, citizenship status, genetic information or any other factor which cannot lawfully be used as a basis for an employment decision. We require applications to be completed online. If you wish to view NYU Langone Health's EEO policies, please click here. Please click here to view the Federal 'EEO is the law' poster or visit https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm for more information. To view the Pay Transparency Notice, please click here.
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Internal Number: 67572195
About NYU Langone Medical Center
NYU Langone Health is a world-class, patient-centered, integrated academic medical center, known for its excellence in clinical care, research, and education. Included in the 200+ locations throughout the New York area are five inpatient locations: Tisch Hospital, its flagship acute-care facility; Rusk Rehabilitation, ranked as one of the top 10 rehabilitation programs in the country; NYU Langone Orthopedic Hospital, a dedicated inpatient orthopedic hospital with all musculoskeletal specialties ranked top 10 in the country; Hassenfeld Children's Hospital at NYU Langone, a comprehensive pediatric hospital supporting a full array of children's health services; and NYU Langone Hospital—Brooklyn, a full-service teaching hospital and level 1 trauma center located in Sunset Park, Brooklyn. Also part of NYU Langone Health is the Laura and Isaac Perlmutter Cancer Center, a National Cancer Institute–designated cancer center, and NYU School of Medicine, which since 1841 has trained thousands of physicians and scientists who have helped to shape the course of medical history.