Schedule: Monday - Friday (40 hrs/wk) 8:00 AM - 5:00 PM
Department: Quality Systems & Support - 252
Primary Purpose:
The Quality Supervisor: Blood Bank and Transfusion Services reports to a quality manager and supports the daily operation of the Quality Systems & Support (QSS) department and the quality functions of the Transfusion Medicine division. They promote and coordinate efforts to implement quality processes, standardization efforts, and best practices in specific area of oversight. The Quality Supervisor's role is to support maintaining and improving upon the quality management system in transfusion medicine in alignment with CAP, AABB, FDA, CLIA, ISO and DNV. This role supports internal and external audits, risk assessments, and quality driven process improvements while serving as a liaison between ARUP and the University of Utah staff to address quality issues and lead corrective and preventive (CAPA) actions. The Quality Supervisor monitors and coordinates the daily operational activities of assigned Quality Systems and Support staff. The Quality Supervisor is responsible for: development, performance management, performance appraisals and promotions of associated (QSS) staff under their assigned purview.
About ARUP:
ARUP Laboratories is a national clinical and anatomic pathology reference laboratory and an enterprise of the University of Utah and its Department of Pathology. Based in Salt Lake City, Utah.
ARUP proudly hires top talent to create a work environment of diversity, professional growth and continuous development. Our workforce is committed to the important service we provide to over one million patients each month. We always strive for excellence and have a strong desire to have involvement with the advances in medicine and the role laboratory services plays within each patient's life. We never forget that there is a patient behind every specimen we receive.
We are looking for individuals who want to contribute to ARUP's culture of accountability, integrity, service, and excellence. Consider joining our dynamic team.
Essential Functions:
Supports the adoption and implementation of quality-related strategic department and organizational objectives in functional area of responsibility. May also lead strategic, organizational projects as applicable.
Demonstrates knowledge of applicable regulatory requirements of federal, state, and local governments and other accrediting and licensure bodies pertaining to medical laboratories (e.g., FDA, CAP, CLIA, ISO, AABB, etc)
Provide regulatory oversight for sample and biological waste sales, BECS validations (IT Synergistics for Blood Services and Haemonetics Safe Trace Tx for Transfusion Services), and emergency/scheduled out -of-hospital transfusions.
Responds to requests for immediate investigation and review of critical issues, facilitates corrective actions when needed
Consults with the Manager of Privacy & Risk and the Compliance Manager regarding issues where appropriate
Leads department and hospital-driven quality-related initiatives and post-implementation evaluations of quality processes (e.g. patient identification, blood administration, education audits).
Represents the quality department in cross functional committees and improvement teams
Trains lab and quality team members on quality standards and best practices; may also support organization-wide training and communication
Supports regulatory inspections, assessments and audits; leads corrective action and root cause analysis responses.
Facilitates root cause analysis investigations and CAPA processes. Applies systems-based thinking in the identification of appropriate corrections.
Maintains awareness of new/revised standards and performs gap assessments; presents findings to lab and medical director leadership.
Updates personal skills and knowledge to remain current and become efficient and proficient in the position
Supports and contributes to the development of the department's and/or organization's quality goals and objectives that are supportive of the organization's Quality Management System (QMS) and strategic priorities
Establishes ongoing Quality Assurance and Quality Improvement programs within the area of responsibility.
Regularly reviews appropriate indicators and initiates any necessary preventive actions.
Oversees transfusion medicine-specific regulatory processes including Biological Product Deviations (BPDs), Post Donation Information (PDI) tracking, recalls and lookbacks.
Fulfills and supports Quality Responsibilities as outlined by AABB.
Other duties as assigned.
Physical and Other Requirements:
Stooping: Bending body downward and forward by bending spine at the waist.
Reaching: Extending hand(s) and arm(s) in any direction.
Mobility: The person in this position needs to occasionally move between work sites and inside the office to access file cabinets, office machinery, etc.
Communicate: Frequently communicate with others.
PPE: Biohazard laboratory environment that requires use of personal protective equipment in accordance with CDC and OSHA regulations and company policies.
ARUP Policies and Procedures: To conduct self in compliance with all ARUP Policies and Procedures.
Sedentary Work: Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects.
Fine Motor Control: Picking, pinching, typing or otherwise working, primarily with fingers rather than with the whole hand as in handling.
Vision: Having close, far, and peripheral visual acuity to perform a variety of tasks such as make general observations of depth and distance.
Bachelor's Degree or better in Other: See Notes or related field.
Master's Degree or better in Other or related field.
Bachelor's degree in related field OR Bachelor's degree in any field, plus 10 years of applicable industry experience
Seven (7) years of blood bank and/or transfusion medicine experience with increasingly responsible positions
Five (5) years of experience in quality management systems (e.g. root cause analysis, CAPA, audits)
One or more of the following: Master's degree, ASCP/AMT, or ASQ certification
Prior supervisory experience
Applicable ASCP or AAB
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