Quality Assurance Specialist - Medical Laboratory in Newtown Square, PA at Quest Diagnostics

Job Description

Position: Quality Assurance Specialist - Medical Laboratory 

Location: Newtown Square, Pennsylvania -

Schedule: M-F 8AM - 5PM

Basic Purpose:
Our goal is to provide every patient and every customer with services and products of superior
quality. We do that through commitment, leadership, and establishing rigorous processes which
we measure and continually improve upon.

Duties and Responsibilities:
The QA Specialist position is intended to provide oversight and support for the Quality Program-Quality Management Planning, inspection preparedness and responses associated with laboratory accreditation, non-conformance management and Document Control management, and training and competency monitoring.
Work with the Laboratory Director and Department Supervisors to facilitate the Quality Management Planning process.
Identifying and monitoring quality indicators
Schedule and conduct Quality Meetings and distribute the minutes
Ensure inspection preparedness by conducting internal audits of laboratory processes to identify non-conformances and areas of needed improvement.
Appropriate Authorization, Delegations, and associated Performance Assessments
Training and Competency documented via MediaLab
Testing Exceptions
Effectively create and complete Corrective and Preventive Actions (CAPAs) for areas where non-conformances are identified.
Immediate Corrective Actions
Preventative Actions with Patient Remediation
Continuous monitoring and Effectiveness Checks
License Coordinator for accreditation licensure.
QA Record organization and adherence to record retention requirements.
Responsible for management of the CAP website as applicable for the organizational profile as well as testing and supervisory personnel.
SmartSolve Software Administration for Document Control
Manage SOP Life Cycle (Implementations, Recurring Reviews, Administrator monitoring reports)
Quality metrics data collection and analysis to identify trends and needed interventions.
Other duties as assigned

Supervision Exercised:
None

Qualifications:
Education: Bachelor’s Degree (Medical Technology or Chemical, Biological, or Clinical Laboratory Science)
Work Experience: At least three years’ experience and associated knowledge of Laboratory regulations (CMS/CAP/NYS) and accreditation processes in a Medical Laboratory-Clinical or Anatomic Pathology.
Lean Six Sigma (Continuous Improvement) experience preferred
Technical Training or Professional Licensing: At least three years’ experience and associated knowledge of Laboratory regulations (CMS/CAP/NYS) and accreditation processes in a Medical Laboratory-Clinical or Anatomic Pathology.
Lean Six Sigma (Continuous Improvement) experience preferred
Other: PC application skills in Microsoft Office including Excel and Access.