Quality Assurance Scientist; PSRSI

Overview

Department Information

Control and Public Health Response

This requires Colorado Residency to apply

This is an on-site position

We are committed to increasing the diversity of our staff and providing culturally responsive programs and services. Therefore, we encourage responses from people of diverse backgrounds and abilities.

Be BOLD.....Make a REAL difference . . and join us in serving our communities advancing Colorado's health and protecting the places we live, work, learn, and play, to create a healthy and sustainable Colorado where current and future generations thrive.

Our mission… is to advance Colorado's health and protect the places we live, work, learn, and play.
Our vision… is to create a healthy and sustainable Colorado where current and future generations thrive. In addition to free parking, access to RTD bus lines, Cherry Creek bike path and flexible working arrangements, review additional benefits and perks at the linked page.

Description Of Job

The Division of Disease Control and Public Health Response (DCPHR) is the department’s lead surveillance, planning and response arm for public events including communicable disease outbreaks and epidemics, pandemics, bioterrorism, and other public health and mass casualty events and disasters. The division includes the Office of Emergency Preparedness and Response;
State Public Health Laboratory
; Health Equity Branch, Communicable Disease Branch;
Immunization Branch;
Public Health Informatics
, Reporting, and Refugee Branch
; and Operations Branch
. The Division exists to ensure that the Department has the ability to effectively prepare for, monitor, detect, diagnose, investigate, and nimbly respond to all types of conditions, events and disasters that impact the public’s health.

The Work Unit

The Quality Assurance unit oversees the Quality Management System (QMS) of the State Public Health Laboratory for the Colorado Department of Public Health and Environment. The unit is responsible for the laboratory meeting regulatory compliance, quality assurance, and quality improvement by the development, review, implementation, and communication of all laboratory quality process.

What You Will Be Doing

The QA Scientist supports the mission of the laboratory by ensuring that the highest possible quality of service is provided through the development and maintenance of a comprehensive QA Program. The position tracks regulatory compliance of ISO 17025:2017, FDA, CLIA and EPA regulations. Performs internal QA audits, and makes recommendations to QA Supervisor and Program Managers of units performing testing under these regulations to resolve quality issues and to improve efficiencies in the regulated laboratory units.

• Quality System Management:
  Serves as subject matter expert for ISO 17025:2017, FDA and EPA requirements in the quality management systems (QMS); provide knowledge on other lab regulations (including CLIA). Pulls reports from iPassport and prepares meeting agendas.
• Participates in programmatic and supervisory QA meetings.
• Maintains the iPassport regulatory compliance software system (including assigning & completing tasks, maintaining organization units or OUs and uploading documentation) to support effective QA document control.
• Performs internal QA audits, documents findings and assigns non-conformance tasks to address audit findings to unit staff according to established procedures.

• Quality Assurance Procedures for Regulated Laboratories:
  Documents and record keeping; ensures staff compliance with agency quality management system and statutory, regulatory, accreditation, and licensing requirements for documentation and recordkeeping in relation to the health and safety management systems. Responsible for maintaining the document control platform tracking all SOPs and division policies for regulatory compliance. Monitors the policies, processes, and procedures related to QA.

• QA Training:
  This position utilizes existing staffing levels to maintain and manage functionality of the program by providing cross-training of staff to ensure all staff are well trained in Quality Assurance. This position solicits input on all laboratory related…