Location
Huntingdon Valley, Pennsylvania, USA
Summary
The Clinical Laboratory Quality Assurance Manager is responsible for ensuring compliance with regulatory standards to support laboratory operations, quality and the quality management system, and to promote a culture of safety. The Clinical Laboratory Quality Assurance Manager ensures operational, business, outreach and compliance response functions for the MSB Clinical laboratory. The Clinical QA Manager manages the Quality Plans for the Clinical MSB Laboratory. Coordinates all quality assessments and performance improvement activities for the Laboratory. Serves as Laboratory Compliance Officer and manages the Compliance Program to ensure compliance with all Federal, State and accreditation requirements for all laboratory operations and testing performed. Researches, monitors, updates and communicates laboratory regulatory and quality issues.
This role is part of the Quality function, reporting functionally to the VP of Operations and hierarchically to the VP of QA&RA.
Essential Functions
Quality Assurance and Compliance
- Implement and maintain the quality assurance program to measure, assess and improve the quality of laboratory services, monitor and evaluate activities and identify risk areas through application and integration of Lean management practices.
- Monitor internal Quality Assurance and Quality Control (QAQC ) activities, including the design of standard operating procedures, method detection limits and data quantification; assure documentation and quality assessment of laboratory functions.
- Manage and maintain quality systems for general compliance with the laboratory QA manual and certification/compliance requirements.
- Update quality systems when necessary, working with lab management to address issues of non-compliance and to identify and implement necessary processes and improvements.
- Maintain proficiency with Clinical Laboratory Improvement Amendments (CLIA), ISO15189 and other state and federal regulatory guidelines.
- Analyze and interpret national standards, guidelines, regulations and laws pertaining to clinical laboratory quality management and safety.
- Work with staff and Regulatory Affairs to document regulatory compliance and use data collection tools to assess compliance with regulatory and accrediting agency standards.
- Assist with monitoring and coordinating documentation for proficiency testing programs.
- Oversee all activities for laboratory licensing and collection station licenses
- Maintain all necessary documents and materials pertaining to licensing requirements
- Perform internal audits in all laboratory sections against CLIA, CAP, NYS, ISO15189
- Responsible for ensuring complete and accurate readiness for all inspections
- Effectively coordinates Quality Management meetings and prepares agendas and minutes using standardized formats.
Safety
- Serve as Laboratory Safety Officer, providing guidance and direction to ensure that overall safety and security standards are followed and amended in response to federal and state regulations, audits, or other directives.
- Maintain documentation and assist with implementation of staff education, including safety and security, follow-up of incident reports/corrective action reports, and quality assurance.
- Assist during safety audits
- Represent the Laboratory on monthly departmental safety committee meetings.
- Seek funding support for both quality assurance and Laboratory System improvement activities.
- Assist lab management to coordinate activities across the MHD program areas, such as epidemiology, emergency response, and other relevant programs.
Education and Experience
- Bachelor's degree in Biology, Chemistry, Medical Technology or a related science. MS is preferred
- Minimum 3 year of experience in a clinical laboratory is required.
- Experience in Clinical Molecular Pathology and NGS is highly preferred
- Experience as a Generalist or in multiple CLIA defined specialties is highly preferred.
- Prior experience in a quality related position and/or performing internal audits is a plus.
Work Environment
This job operates in an office and clinical laboratory setting.
Physical Demands
This is largely a sedentary role. However, it will require the ability to lift files, open filing cabinets and bend or stand as necessary.
Position Type/Expected Hours of Work
This is a full time, exempt, professional-level position. Typical days and hours of work are Monday through Friday, 9:00 a.m. to 5:00 p.m. however, this position may require some flexibility to accommodate hour changes due to a high growth business.
Travel
This position does not usually require frequent travel.