St. John’s, established in 1870, has two New York City campuses; international locations in Rome, Italy; Limerick, Ireland; and Paris, France; and study abroad locations around the world. The Princeton Review and other top rankings consistently recognize the University’s outstanding academics, diverse student body, dynamic internship, and volunteer opportunities, focus on student life, and diverse study abroad offerings. St. John’s University offers more than 100 undergraduate and graduate programs in its six colleges and schools, with a growing number of programs offered online. The University is accredited by the Middle States Commission on Higher Education and 12 other major academic and professional associations. 
 
A dedication to diversity, equity and inclusion is at the heart of our mission.  As a Catholic and Vincentian university, St. John’s is committed to institutionalizing practices of inclusive excellence to ensure that we welcome and celebrate the intrinsic worth of all members of our community.  We will become an even stronger university as we enhance equity at every level of our institution. Our graduates will excel in the competencies and values needed for leadership and service in a rapidly evolving world.  

Job Title: General Supervisor/Quality Assurance Manager

Reports To: Laboratory Director

Position Summary:
The incumbent will be responsible for overseeing testing personnel, ensuring that laboratory operations adhere to established performance specifications, managing the Quality Assurance Program, and implementing corrective actions as necessary. The position requires a strong understanding of laboratory procedures, proficiency testing, and quality assurance activities. This role will play a crucial part in maintaining high standards for patient test performance and ensuring the laboratory's compliance with quality assurance requirements.

Key Responsibilities:

1. Patient Test Procedures:

• Follow the laboratory's pre-analytic and analytic procedures and maintain records of tests;
• Maintain records that demonstrate that proficiency testing samples are tested in the same manner as patient specimens;
• Adhere to the laboratory's quality assurance procedures, including documenting all:
  • quality control activities;
  • instrument and equipment verifications;
  • maintenance and preventive maintenance; and
• Follow the laboratory's policies and procedures whenever test systems are not within the laboratory's established performance specifications;
• Identify and document problems that may adversely affect test performance and notify the supervisor, assistant director(s), or director; and
• Document all corrective actions taken when test systems deviate from the laboratory's established performance specifications.

Laboratory Supervision:

• • Supervise testing personnel;
  • Monitor and ensure that acceptable performance specifications are maintained, including:
    1. review of quality control;
    2. scheduled instrument and equipment maintenance;
    3. other quality assurance activities as assigned; and
  • Ensure test system performance:
    1. by initiating preventive and/or remedial actions when test procedures deviate from the laboratory's established performance specifications;
    2. in the event of nonconformances, ensuring that test results are not reported until corrective action has been taken and the test is performing according to laboratory established performance specifications; and
  • Verify that personnel are trained and deemed proficient prior to performing testing on patient specimens independently;
  • Ensure that staff have competency assessments as needed; and
  • Ensure action is taken when personnel do not perform as expected on competency assessments.

Quality Assurance Program Management:

• • Collaborate with the clinical laboratory director and technical director to set quality goals, performance indicators, and performance expectations and/or thresholds.
  • Regularly review quality goals and ensure that performance expectations are met.
  • Continuously monitor for deviations from quality goals or performance expectations.
  • Schedule and perform audits of systems and processes, at least annually, and ensure corrective actions are taken for any identified problems.
  • Implement and maintain Continuous Quality Improvement (CQI) processes, quality indicator monitoring, and internal audits.
  • Manage the documentation of the Quality Management System and participate in management reviews.

Qualifications:

The laboratory supervisor must meet one of the following requirements:

• (a    Be a physician licensed to practice medicine or osteopathy in the State of New York, or an individual who has earned a doctoral degree from an accredited institution with a chemical, physical or biological science as the supervisor's major subject and either holds a certificate of qualification or qualifies as a clinical laboratory technologist. This supervisor shall, subsequent to graduation, have at least one (1) year of pertinent experience in an acceptable laboratory.

OR 

• (b   Holds a master of arts or master of science from an accredited institution with a major in one of the chemical, physical or biological sciences; qualifies as a clinical laboratory technologist; and, subsequent to graduation, has had at least two (2) years of pertinent experience in an acceptable laboratory.

OR

• (c The supervisor is qualified as a clinical laboratory technologist and has had at least four (4) years of pertinent experience in an acceptable laboratory subsequent to qualifying.

Additional Skills:

• Knowledge of regulatory requirements (e.g., CLIA, CAP) and compliance standards in laboratory environments.
• Strong knowledge of laboratory procedures, quality control, and quality assurance standards.
• Familiarity with proficiency testing and corrective action documentation.
• Adherence to competency requirements.
• Strong leadership skills with the ability to supervise and motivate staff.
• Excellent organizational and time management abilities.
• Ability to handle complex problem-solving and make decisions under pressure.
• Strong communication skills, both written and verbal.

Work Environment:

• The role will be based in a clinical laboratory environment with responsibilities spanning both administrative and operational duties.
• Adherence to laboratory safety protocols is required, including the handling of biological samples, reagents, and chemicals.
• The position involves regular interaction with laboratory personnel and management, as well as periodic audits and assessments.
• Ability to work in a fast-paced environment, with occasional demands for long hours depending on operational needs.