Specialist, Quality Assurance

Quest Diagnostics; Oklahoma City (OK); On-site; USD 70,000 - 90,000; Full time

Job summary

Quest Diagnostics is seeking a dedicated Specialist, Quality Assurance, Compliance & Safety to oversee the Quality Program, manage inspection readiness, CAPAs, and document control within a clinical laboratory setting.

The role supports governance of regulatory compliance, privacy monitoring, and safety initiatives, reporting to the Quality Assurance function. Travel up to 25% may be required across sites as needed.

Qualifications

• At least three years’ experience and knowledge of Laboratory regulations (CMS/CAP/NYS) and accreditation processes in a Medical Laboratory-Clinical or Anatomic Pathology.
• Minimum of 3 years Quality Assurance experience.

Responsibilities

• Assist with quality management planning and inspection preparedness.
• Identify and monitor quality indicators and conduct internal audits.
• Prepare and distribute Quality Meeting minutes and maintain records.
• Create CAPAs for identified non-conformances and implement corrective actions.
• Support training, competency monitoring, and document control processes.
• Assist with safety audits, meetings, SDS, and JHA compliance.
• Support privacy incident monitoring and corporate compliance activities.

Skills

PC application skills in Microsoft Off

Education

Bachelor’s Degree (Medical Technology or Chemical, Biological, or Clinical Laboratory Science)

Job description

Job Description

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.

Responsibilities

The Specialist, Quality Assurance, Compliance & Safety 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.

Quality Assurance

• Work with the Laboratory Director and Department Supervisors to facilitate the Quality Management Planning process.
• Identify and monitor 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.

Safety

• Assists in safety audits, inspections, internal and external regulatory activities.
• Assists with monthly safety meetings, SDS, JHA’s
• Facilitate in ensuring safe environment is maintained
• Ensures corporate safety protocols are followed
• Ensures Safety is part of the Quality Management Plan

Compliance

• Assist in monitoring privacy incidents in Radar
• Ensures corporate compliance protocols are followed
• Helps interact with corporate compliance in applicable scenarios
• Helps ensure public health reporting protocols are followed

Qualifications

Required 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.
• Minimum of 3 years Quality Assurance experience.

Preferred Work Experience

• Lean Six Sigma (Continuous Improvement) experience preferred
• Lab experience preferred

Physical And Mental Requirements

• Indicate any physical or mental demands that must be met to successfully perform the principal responsibilities of the position (e.g., routinely lift 25 pounds, sitting or standing for long periods of time.)

Technical /Job Specific Knowledge

• Knowledge of Laboratory regulations (CMS/CAP/NYS) and accreditation processes in a Medical Laboratory-Clinical or Anatomic Pathology.

Skills

• PC application skills in Microsoft Office including Excel and Access.

Education

• Bachelor’s Degree Bachelor’s Degree (Medical Technology or Chemical, Biological, or Clinical Laboratory Science) (Required)

Work Requirements

• Minimal Travel Required - Upto 25%

About The Team

Quest Diagnostics honors our service members and encourages veterans to apply. While we appreciate and value our staffing partners, we do not accept unsolicited resumes from agencies. Quest will not be responsible for paying agency fees for any individual as to whom an agency has sent an unsolicited resume.

Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets or any other legally protected status.