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Quality Specialist Technologist - Molecular
Ref No.: 17-00286
Category: Medical / Health
Location: Aliso Viejo, California
The Quality Specialist Technologist works under minimal supervision and demonstrates proficiency in core responsibilities of a Clinical Laboratory Technologist and perform duties as assigned. This is the advanced level for the Technologist job category responsible for assisting the department supervisor/manager, 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.

Core Responsibilities
  • Demonstrated proficiency in core responsibilities of a Clinical Laboratory Technologist and perform duties as assigned.
  • Attend the Quality Monthly Meeting and any other quality meetings as required. In attendance, the QST is the representative of the department and is required to communicate information from the Quality meeting to the departypical communication means.
  • Facilitates discussion and communication of quality initiatives/requirements or Quality Meeting updates at department staff meetings.
  • 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 department manager to implement and improve document management. Ensures that all departmental Standard Operating Procedures and Forms are reviewed and current.
  • Ensure that all department employees are assigned to the correct Quality Group for correct assignment of departmental Standard Operating Procedures. Ensure that all current Standard Operating Procedures are accurate and match departmental operating practices.
  • As Quality SME will be the point of contact and coordinate/assist employees with the navigation of the MediaLab Document control module.
  • Support the department manager with the training and competency program. Become the expert and SME of the Compass training and Competency module. Assist in developing and managing forms and requirements in MediaLab for Training and Competency. Ensure that all the necessary department employees are correctly assigned to the appropriate training and competencies.
  • Support the department manager in ensuring that the training and competencies are performed in a timely manner.
  • Support the department manager in executing the Non-Conforming Events Program [NCEP] (CAPA, Customer Complaints, Deviations, etc.). As the SME for NCEP the QST will be the primary resource to assist department staff with navigation the NCEP in SalesForce, assist department staff with reporting identified NCE's in SalesForce as well as assisting department staff with training on the processes and various ways of identifying NCE'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 manager.
  • Will follow-up audit findings with corrective actions and effectiveness monitoring as requested by the department manager.
  • Will make sure all audit findings are closed out with completeness of appropriate documentation.
  • AS Quality SME the QST will collaborate with compliance, 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.
  • On behalf of the department manager oversees the departments' annual competency testing of laboratory staff through process and documentation as assigned.
  • 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 assigned.
  • Will follow-up on MOC documentation on behalf of the department as assigned.
  • Will make sure all instrumentation documentation is accurate and complete, such as IQ/OQ/PQ instrumentation qualification.

Qualifications:
  • Shift: Monday Through Friday 8:30 to 5:00 PM
  • Nationally: ASCP certification for the assigned specialty, as available
  • CA: current state license to perform laboratory testing
  • Bachelor's Degree from an accredited college or university in one of the chemical, physical, or biological sciences with the addition of at least 1 years of laboratory experience/training/training course required. Bachelor's or Master's Degree in Medical Technology from an accredited college or university preferred.
  • Five or more years of equivalent experience (high complexity testing) preferred