Address
Form of workSchedule:
Monday - Friday (40 hrs/wk)
8:00 AM - 5:00 PM
Department: PharmaDx Quality - 506
Primary Purpose:
The Quality Manager formulates strategic goals, develops and manages a budget, assigns objectives, and establishes standards of practice for the assigned group within the PharmaDx quality assurance team. The Quality Manager recommends and implements processes for the PharmaDx department related to the functions of the quality assurance team. The Quality Manager coordinates and monitors the daily operational activities of the quality assurance team and serves as the liaison for the group with other functional units of the organization. Salary starting at $118k to $142k (mid-range) and will be commensurate with experience.
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:
Support the Director of Quality & Regulatory Affairs with the operation of the PharmaDx department. When requested, take responsibility for operations in the absence of the Director of Quality & Regulatory Affairs.
Develop, prioritize, and manage quality goals and objectives for the assigned group that align with departmental and organizational strategic priorities.
Demonstrate advanced knowledge of current regulatory requirements of federal, state, and local governments and other accrediting and licensure bodies pertaining to medical laboratories (e.g., ISO, FDA, IVDR, CAP/CLIA, GMP, PMDA, ROW standards).
Provide resource and support for the implementation of quality processes.
Develop and perform internal and external audits, mock inspections and surveys. Provide recommendations based on findings and ensure implementation of appropriate responsive actions.
Consult with clients/partners and respond to quality questions in a timely manner.
Develop and deliver employee and client/partner education and training in quality-related areas.
Consult with the Director of Quality & Regulatory Affairs regarding projects, including developing and monitoring project timetables, deliverables, project communications and progress reports, and other project requirements.
Develop and maintain all necessary procedures related to departmental and organization quality management system activities.
Establish ongoing Quality Assurance and Quality Improvement programs for the department. Regularly review appropriate indicators and initiates any necessary corrective actions.
Where appropriate to the task, the Quality Manager may delegate any duties to subordinate supervisors, leads, coordinators, or staff.
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.
