- Workplace: On-site daily
- Regular or Temporary: Regular
- Weekly Working Hours: 40.00
- AIP Target %: 5
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%
