Laboratory Compliance Officer (PSRSI)

at  State of Colorado Job Opportunities

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 safety and accuracy of laboratory testing are the primary concerns of the Certification Program. The staff endeavors to protect the public health through education and inspection of facilities that perform laboratory testing services. Various state and federal regulations are administered through the Certification Program. The facilities include clinical laboratories regulated under the Clinical Laboratory Improvement Amendments (CLIA ‘88), drinking water testing laboratories under the Environmental Protection Agency (EPA) Safe Drinking Water Act, milk producer laboratories and other milk testing laboratories under the Food and Drug Administration (FDA) Grade A Pasteurized Milk Ordinance of 1995, and law enforcement and private alcohol and drug testing laboratories under the Colorado State Board of Health Rules and Regulations 5CCR 1005-2.

MINIMUM QUALIFICATIONS:

An applicant may meet the minimum qualifications for this job in one of two ways. They may qualify through their work experience alone or through a combination of education and work experience
Experience Only:
Five (5) years of professional experience* in a clinical or analytical laboratory, or CLIA certified diagnostic laboratory.
OR
Education and Experience:
A combination of related education* in a chemical, physical, or biological science, or medical technology, or closely related degree and/or relevant experience in a clinical or analytical laboratory, or CLIA certified diagnostic laboratory equal to five (5) yearsThis experience must be substantiated within the Work Experience section of your application. “See Resume” will not be accepted. In addition, part-time work will be prorated. A copy of your transcript must be submitted at the time of application (Unofficial transcripts are acceptable.)

PREFERRED QUALIFICATIONS AND ESSENTIAL COMPETENCIES:

The preferred experience, competencies and abilities are highly desirable for this position and will be considered in selecting the successful candidate.

• Relevant years of State service
• Certified Medical Technologist with three or more years of full time experience testing samples in multiple specialties and subspecialties in a CLIA certified laboratory
• Master’s or doctoral degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution and three years of full time experience testing samples in a clinical or analytical laboratory
• Knowledge of federal Clinical Laboratory Improvement Amendments (CLIA) requirements
• Knowledge of ISO 17025
• Knowledge of food, clinical, environmental, or pharmaceutical, laboratory analysis technology
• Advanced knowledge of laboratory quality control and quality assurance
• Demonstrated analytical method development and validation experience with a variety of difficult sample matrices
• Experience writing laboratory standard operating procedures (SOPs)
• Experience using a Laboratory Information Management System (LIMS)
• Ability to effectively communicate both orally and in writing with a wide range of customers/stakeholders
• Excellent critical thinking and problem solving skills
• Ability to interpret regulations and statutes
• Ability to work well independently as well as in/with a team
• Experience testing samples for compliance with regulatory requirements
• Excellent writing skills
• Excellent interpretation skills
• Excellent oral communication skills
• Excellent data analysis and reporting skills
• Excellent planning and organizing skills
• Relevant years of State service contribute to a candidates position-related knowledge, skill, ability, behavior or other posted competency should be considered as a preferred qualification and given weight under the process.

Conditions of Employment:

• Pursuant to CDPHE policy, a criminal history background check is required for all positions at CDPHE
• Must be available in the event of an emergency, (e.g., bio-terrorist attack, chemical attack, disease outbreak or all hazards) and be required to report to work immediately at the regular or alternate location. During this time, travel restrictions may be in place.
• Must be available in the event of the activation of the Continuity of Operations Plan (COOP) and be required to report to work immediately at the regular or alternate location. During this time, travel restrictions may be in place.
• Hybrid position and will require time on-site that is determined by the division/manager.
• Ability to travel 50% of time to perform inspections alone.

This position exists to determine compliance with the Clinical Laboratory Improvement Amendments (CLIA) and the Rules Pertaining to Testing for Alcohol and Other Drugs (5 CCR 1005-2) regulations for laboratory testing. The surveyor applies these state and federal regulations to foster good laboratory practices through on-site and off-site inspections of medical and forensic toxicology laboratory facilities within Colorado. The surveyor analyzes data, prepares written reports, performs complaint investigations and communicates with laboratories.