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Quality Specialist Technologist - Histology
Ref No.: 20-00495
Category: Biotechnology
Location: Ft Myers, Florida
RELOCATION/SIGN-ON BONUS OFFERED

TheQuality Specialist Technologistworks under minimal supervision and shows knowledge in the core responsibilities and functions of aHistotechnologist (HTL).This is the advanced level for the HTL job category responsible for assisting the department supervisor/manager, who are ultimately responsible for the execution of quality imperatives. You will assist in the implementation of key priorities and supporting quality requirements and initiatives in department operations.
  • Perform functional duties as liaison for our quality group.
  • As the Quality SME, you will lead high quality standards by executing effective Quality management systems.
  • We want all quality associated documents, change-control procedures, and processes are complete and current.

Responsibilities:
  • Attend the Quality Monthly Meeting and any other quality meetings as required. In attendance the QST is the representative and is required to communicate information from the Quality meeting to the department through typical 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, as well as the liaison with the Quality Department.
  • With help from the manager, you will implement and improve document management, and promote that all Standard Operating Procedures and Forms are reviewed and current.
  • You will assign employees to Quality Groups for correct assignment of departmental SOPs, and make sure of accuracy to match departmental operating practices.
  • You will be the point of contact and coordinate/assist employees with the navigation of the MediaLab Document control module.
  • You will help the manager with the training and competency program, and become the expert of the Compass training module; and handle forms and requirements in MediaLab.
  • In this role, you will promote 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.
  • You will perform self-inspection and cross-functional inspections as defined and stand as the key contact for preparation and servicing internal/external audits as requested.
  • You will follow-up audit findings with corrective actions and effectiveness monitoring as requested; and push that all audit findings are closed out with completeness of appropriate documentation.
  • As a team, we 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. You will document root cause analysis if needed.
  • Reviews department activities to ensure compliance with departmental polices and federal, state and local regulations.
  • With the manager, we will handle the departments' annual competency testing of laboratory staff through process and documentation as assigned; and ensure that all change control [MOC] documentation of change is completed as assigned.
  • You will initiate and follow up on MOC documentation as needed.
  • You will make sure all instrumentation documentation is accurate and complete, such as IQ/OQ/PQ instrumentation qualification, and ultimately assist operational management in maintaining an inspection-ready laboratory and department.

Qualifications:
  • Bachelor's degree from accredited college/university
  • Nationally:HT or HTLASCP certificationstrongly preferred
  • Five or more years of experience in a high complexity testing preferred