Quest Diagnostics
Spec QA/Compliance/Safety- Newtown Square, PA req49357
At a glance
Location: US-PA-Newtown Square Map
Posted: 10/25/2020
Closing: 11/24/2020
Degree: Not Specified
Type: Full-Time
Experience: Not Specified
Quest Diagnostics
Job description

Spec QA/Compliance/Safety- Newtown Square, Pennsylvania - M-F 8AM - 5PM

Look for more than answers. Patients and Physicians rely on our diagnostic testing, information and services to help them make better healthcare decisions. These are often serious decisions with far reaching consequences, and require sensitivity, tact and a clear dedication to service. It’s about providing clarity and hope. 

You will work for the world leader in the industry, with a career where you can
expand your skills and knowledge. You’ll have a role where you can act with
professionalism, you can inspire colleagues, and you can care about the work we do and the people we serve. 

At Quest, we are on a continuous journey of discovery and development. It’s this attitude that has made us an industry leader and the #1 Diagnostic Lab in the US. For those joining us, we offer exciting and fast moving career opportunities where you can affect change at a rate unheard of in many organizations of our size and scope. While we invest in and develop technology to drive our innovations, our ongoing success relies on our people.

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:
Provide support for the Quest Quality Program-Quality metrics, record management, laboratory certification, and monitoring laboratory processes through audits.
Work with the Laboratory Director and Department Supervisors to facilitate the Quality Management Planning process.
Quality Plan Management
Schedule and conduct Quality Meetings and distribute the minutes.
Ensure inspection preparedness by conducting internal audits of laboratory processes to identify compliance gaps and areas of needed improvement.
Appropriate Authorization, Delegations, and associated Performance Assessments
Training and Competency documented via MediaLab
Equipment Verifications
Reagent management
Testing Exceptions
Effectively create and complete Corrective and Preventive Actions (CAPAs) for areas where compliance gaps are identified.
Immediate Corrective Actions
Preventative Actions with Patient Remediation
Continuous monitoring and Effectiveness Checks
Manage Quality Event documentation and escalation as applicable.
License Coordinator for accreditation licensure.
QA Record organization and adherence to record retention requirements.
Responsible for management the CAP website updates as applicable for organization profile, testing personnel, 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

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.
Lean Six Sigma (Continuous Improvement) experience preferred

Physical and Mental Requirements: None

Technical Training or Professional Licensing: At least three years’ experience and associated knowledge of Laboratory regulations (CMS/CAP/NYS) and accreditation processes.
Lean Six Sigma (Continuous Improvement) experience preferred

Other: PC application skills in Microsoft Office including Excel and Access.

Spec QA/Compliance/Safety- Newtown Square, PA req49357