Job Board

Manager QM - Quality Assurance Manager, Blood Bank

Montefiore Medical Center's Division of Clinical Pathology is responsible for the laboratory testing of blood, urine, and body fluids for disease diagnosis and health maintenance. Utilizing the latest advances in computer technology, the Division maintains millions of dollars of state-of-the-art automated equipment at its laboratory sites and services hospitals, nursing homes, the Montefiore Medical Group, faculty practices, and voluntary physicians' offices at more than 40 sites.

The quality manager is responsible for ensuring that all areas of the MMC Transfusion Service are operating in compliance with applicable government agencies and accrediting agency standards. Responsibilities include designing, implementing, and monitoring of the quality assurance program for all MMC Blood Banks. This includes leading regular internal audits of the laboratories' technical operations to ensure compliance and prevent citations. The quality manager is responsible for overseeing the independent assessments of laboratory analyses and practices without managerial influences, evaluating scientific data, and notifying laboratory management of any deficiencies in the quality systems. The quality manager oversees adverse event reporting and directs and evaluates required corrective actions within the department.  The individual will also manage critical monthly QA management reports of document control, inventory control, temperature control, laboratory software, and other quality system essential metrics. The quality manager will be aware of all in-date blood product retrievals, market withdrawals, recalls, and lookbacks. In addition, the quality manager helps coordinate and oversee quality improvement initiatives within the department.

Responsibilities:

• Manage Quality Management System program to include writing, reviewing, and maintaining policies and procedures; manage and conduct regular and focused technical audits; evaluate data to identify trends of non-conformances and present the non-conformances to members of the laboratory management team
• Support and guide laboratory directors, managers, supervisors, and staff to ensure a full understanding and compliance with the Blood Bank Quality Plan. Provides guidance for training and competency assessment programs to ensure regulatory compliance. Actively educate staff on cGMP procedures and processes
• Assist in writing, development and annual review of blood bank policies and procedures. Oversee document control and procedures
• Manage department regulatory activities to ensure compliance with all local, federal, and national regulatory/accrediting agencies. Reviews current and new regulations, standards, or proposed changes about potential impact on operations or SOPs
• Manage and interface with document control and temperature control software and instrumentation
• Work closely with Pathology QM Team to ensure all records, policies, and procedures are up to date and address any issues
• Provide oversight and coordination for quality improvement activities and metrics with colleagues in Blood Bank/Pathology operations
• Coordinate and actively participate in all accreditation/regulatory inspections. Maintain records for all inspections and aid the management team in the corrective action and follow up in response to inspection citations
• Direct development of corrective action plans to address any non-conformance issues, customer complaint investigation and accident investigation. Provide training and guidance on corrective actions and ensure plans are implemented, followed and effective
• Liaise with all levels of administration, faculty and/or outside organizations to coordinate activities, to accomplish directives and to facilitate the resolution of problems
• Must demonstrate ability to select components for neonatal transfusion
• Perform other duties as defined in the course of work or needed

Qualifications:

• Bachelor's Degree required, Master’s Degree is preferred
• NYS Clinical Laboratory Technologist required
• A minimum of 5 years of work experience required
• Knowledge of automated immunohematology test systems. Software user knowledge in monitoring aspects of laboratory regulatory defined practices. Expert knowledge in regulations pertaining to various regulatory agencies (i.e., CAP, NYS DOH, etc.) required
• Software knowledge: Document/Temperature Control
• Knowledge of procedures for performing tests- ABO/Rh, phenotyping, DAT. Understanding of the principles and limitations of high complexity test procedures- antibody ID, compatibility tests, absorption/elution required
• Ability to validate and/or review validation/verification studies performed in the Blood Bank including but not limited to software and instrumentation

This position is located at the Moses campus in the Blood Bank Lab. The days are Monday through Friday, and the hours are 8:30 am – 5:00 pm.

Salary Range/Pay Rate: $90,000 - $120,000

Qualified candidates should e-mail a résumé, cover letter summarizing their interest and background to Matthew Vig, mvig@montefiore.org.

Montefiore (https://www.montefiore.org) is an equal employment opportunity employer. Montefiore will recruit, hire, train, transfer, promote, layoff and discharge associates in all job classifications without regard to their race, color, religion, creed, national origin, alienage or citizenship status, age, gender, actual or presumed disability, history of disability, sexual orientation, gender identity, gender expression, genetic predisposition or carrier status, pregnancy, military status, marital status, or partnership status, or any other characteristic protected by law.