Specialist, Quality Assurance

This position contributes to the overall QA Program of the laboratory. Responsible for licensure, accreditation and inspection of the laboratory. Accountable for the internal and external quality assurance programs. Position coordinates efforts that promote quality and ensures that all pre-analytical, analytical, and post-analytical processes within the QMS are compliant with CAP, CLIA, GLS, ISO and all other applicable regulatory or certification bodies.

Functions as the representative for the Quality Assurance department to both internal and external functions.

This is a 5 day/Onsite position.

No relocation assistance available.

• Manage Proficiency Testing Program (CAP and NYS) for the laboratory - maintain data base and produce monthly summaries.
• Manage the Document Control System. Support compliance with document control policies for all procedures and related documents.
• Conduct Internal Audits to ensure laboratory is inspection ready at all time and prepare corresponding report.
• Facilitates preparation, distribution, and review of the QA Manual.
• Assist with external audits.
• Review protocols and make recommendations to enhance QA Program.
• Coordinate compliance with applicable regulations through documentation, audits, and corrective action.
• Perform reviews of departmental quality records. Collaborate with management in the testing department to investigate and resolve nonconformances.
• Audit training and competency program.
• Assists to review and approve non-conformances and follows up with nonconformance owner to ensure that corrective actions and preventive actions (CAPA) are implemented and sustained.
• Assist in the prompt and complete reporting of Reportable Quality Issues and Revised and Amended Reports in compliance with the SOP.
• Effectively communicates with Lab Managers, Supervisors, and Quality Coordinators to ensure that employees consistently exhibit behavior that promotes and supports quality of the local business unit and Quest Diagnostic Lab.
• Functions as a resource for laboratory inquiries regarding CAP, CLIA, GLS, ISO and all other applicable regulatory or certification bodies.
• Monitors and reviews Testing Personnel have appropriate licensure, accreditation, and all duties are appropriately delegated as required by applicable federal, state, and local regulations.
• Ensure laboratory enrollment in external Proficiency Testing (PT) programs as required by Quest Diagnostics and regulatory agencies.
• Ensure Alternative Performance Assessment (APA) program is performed on tests that are not covered by external PT programs.
• Assists in compiling data and/or records to create Quality Assurance specific quality indicators, examples include but are not limited to Reportable Quality Issues (RQI), Proficiency Testing outcomes, Revised Reports tracking, and performance of internal and external inspections.
• Reviews or writes General Standard Operating Procedures for the Quality Assurance department or laboratory services.
• Actively supports and complies with all company policies and procedures.
• Promote continuous quality improvement by collaborating with management to implement standardization and process improvement.
• Perform special projects as assigned.
• Perform other duties as assigned to meet the business needs or customer requirements. This is not an exhaustive list of all duties and responsibilities, but rather a general description of work performed by the position.

• Minimum of 2 Years laboratory experience.

• Previous experience with Quality Assurance.

• The normal performance of duties may require lifting and carrying objects:
  Objects 1 to 10 pounds are lifted and carried frequently; objects 11 to…