Quality Specialist Technologist, Anatomic Pathology - Staff Icons

The Quality Specialist Technologist [QST] works under minimal supervision and demonstrates proficiency of core responsibilities performed in a moderate and high complexity testing Anatomic Pathology laboratory and perform duties as assigned. This is the advanced level for the Technologist job category responsible for assisting the department site supervisor/managers, who are ultimately responsible for the execution of quality imperatives. The Quality Specialist Technologist is tasked with assisting in the implementation of key priorities and supporting quality requirements and initiatives in department operations set by the Quality Specialist Technologist Supervisor and/or the Director of Anatomic Pathology.

Responsibilities:

• Attend the Quality Monthly Meeting and any other quality meetings as required. In attendance the QST is the site representative of the department and is required to communicate information from the Quality meeting to the department through typical communication means and/or trainings and facilitates discussion and communication of quality initiatives/requirements
• Act as the Subject Matter Expert [SME] for the Quality Management Program of the department
• Act as a liaison with the Quality Department
• Support the Quality Specialist Technologist Supervisor [QSTS] to implement and improve document management at their site. Ensures that all site departmental Standard Operating Procedures and Forms are reviewed and current
• Ensure that all site-specific department employees are assigned to the correct QMS job codes for correct assignment of departmental Standard Operating Procedures. Ensure that all current Standard Operating Procedures are accurate and match departmental operating practices
• The Quality SME will be the point of contact and coordinate/assist employees with the navigation of the Master Control and Media Lab Document control modules
• Support the department managers with the training and competency program. Become the expert and SME of the Compass training and Competency module. Assist in managing forms and requirements in Master Control and Media Lab for Training and Competency
• Support the department managers in ensuring that the training and competencies are performed in a timely manner
• Support the department managers and QSTS in executing the Non-Conforming Events Program [NCEP] (CAPA, Issue reviews, Customer Complaints, Deviations, etc.). The SME for NCEP will be the primary resource to assist department management, QST, and/or department staff with navigation the NCEP in Master Control, as well as assisting department staff with training on the processes and various ways of identifying IR's
• Attend the CAPA Review Board meetings as requested
• As Quality SME the QST will be able to perform self-inspection and cross-functional inspections as defined. The QST will serve as the key contact for preparation and servicing internal/external audits as requested by the department managers
• Will follow-up audit findings with corrective actions and effectiveness monitoring as requested by the department managers
• Will make sure all audit findings are closed out with completeness of appropriate documentation
• As Quality SME, the QST will collaborate with compliance, QSTS, department management and medical oversight to ensure that appropriate proficiency or alternative assessment testing is in place for required assays as assigned
• Will serve as the primary contact for on-going Proficiency Testing and Alternative Assessment testing as assigned
• Will ensure that all necessary documentation of Proficiency Testing and Alternative Assessment testing is in place and complete
• Will perform and document root cause analysis on unacceptable Proficiency Testing and Alternative Assessment testing as assigned
• Reviews department activities to ensure compliance with departmental polices and federal, state and local regulations
• As Quality SME, the QST will ensure that all change control [MOC] documentation of change is completed as assigned
• Will initiate MOC documentation on behalf of the department as requested
• Will follow-up on MOC documentation on behalf of the department as requested
• Assist operational management in maintaining an inspection-ready laboratory and department

Qualifications:

• Baccalaureate degree from a regionally accredited college/university AND successful completion of a NAACLS accredited Histotechnician or Histology program within the last 5 years; OR Baccalaureate degree from a regionally accredited college/university with a combination of 30 semester hours (45 quarter hours) of biology and chemistry ( must include credit hours in both) AND one-year full time acceptable experience in a histopathology (clinical, veterinary, industry or research) laboratory in the U.S., Canada or an accredited laboratory* within the last ten years.
• Must have a degree in Healthcare Administration
• Nationally: ASCP certification as Histotechnologist (HTL) or Histotechnician (HT) preferred
• 3 years or more years of equivalent experience (high complexity testing) preferred
• FL State License is required