Clinical Trials Quality Control Specialist

Rochester Regional Health

2d•Onsite

About The Position

The Quality Control Specialist is responsible for the oversight and management of quality control standards for Clinical Trials Specimen Management. The Quality Control Specialist will work collaboratively with the CTSM supervisors and Team Leads to ensure quality and best practices in the laboratory. This position reports to the Director of Laboratory Operations.

Requirements

Associates or Bachelor Degree in science

Nice To Haves

4-6 years’ experience in a Quality role within a clinical laboratory/ medical technology setting

Responsibilities

In coordination with Management keeps up with-current understanding of all applicable regulations, requirements and standards in regards to quality control processes.
Performs all work in accordance with requirements of regulatory agencies such as CAP, NYSDOH, CLIA, OSHA, ISO and ISBER.
Participates in CT Lab and CT Specimen Management (CTSM) quality control investigations, root cause analysis, corrective/ preventative actions, and process improvements for the Lab and CTSM.
Works with Lab and CTSM leaders to develop and maintain quality dashboards, quality monitors, regulatory (CAP, NYSDOH) related tasks, key performance indicators and compliance.
Performs routine quality control review of equipment validation and qualifications to ensure compliance.
Performs QC for shipping, storage and routine samples and documents at a percentage determined by management.
Participates in regulatory inspections and client audits by collecting required documentations and provides to Quality Assurance for internal/ external audits for both the Lab and CTSM.
Provides input to appropriate corrective and preventive actions of audit/inspection findings within allotted due date.
Performs a routine check of employee training binders and continuing education to ensure they are maintained by employees of both the Lab and CTSM.
Reviews employee competencies in appropriate areas of the Lab and CTSM to ensure. completion of annual and semi-annual competency assessments of all applicable employees.
Reviews Best practices for the Lab and CTSM space and recommends and implements process improvements to streamline operations between the lab/CTSM and other departments.
Leads and supports Lab and CTSM leadership with process rollout and staff (re)trainings
Supports Lab and CTSM leadership by ensuring the development and updating of standard operating procedures, ensuring quality and regulatory compliance are present in the appropriate time frames.
Other duties as assigned by the manager
Promotes a culture of audit readiness.