Laboratory Compliance Officer (PSRSI)

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.

What You'll Be Doing:
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.

Laboratory Inspections
Using knowledge of applicable regulations, good laboratory practices, and effective methods of data collection, perform on-site and off-site surveys of laboratory testing facilities throughout the state. Transportation is by state owned vehicles when available or by personal vehicle when the state vehicle is not available. Apply effective interview and data gathering skills to ascertain the quality of laboratory testing.

Survey Documentation Processes
Develop accurate, well-organized documentation of observations and factual information obtained on surveys. Based on the appropriate regulations, determine the level of compliance and write reports in electronic format.  Communicate findings with laboratory officials. Demonstrate effective written and oral communication skills. Review written reports for accuracy from other surveyors prior to sending the reports to the laboratories.

Regulatory Compliance Monitoring
Monitor and evaluate plans of correction and evidence of compliance. Recommend certification or enforcement actions to Federal Officials or management. Provide regulatory guidance, education and information to the laboratory community related to regulations and standards. Monitor the Proficiency Testing performance of the labs in order to determine compliance.

Residency Requirement:

MINIMUM QUALIFICATIONS: 

Five (5) years of professional experience* in a clinical or analytical laboratory, or CLIA certified diagnostic laboratory. 

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) years

• 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. 

• 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.

Appeal Rights: 

As an applicant directly affected by the results of the selection or comparative analysis process, you may file a written appeal with the State Personnel Director.

Review of the completed, signed and submitted appeal will be timely on the basis of written material submitted by you, using the official appeal form signed by you or your representative. This form must be completed and delivered to the State Personnel Board by email at dpa_state.personnelboard@state.co.us within ten (10) calendar days from your receipt of notice or acknowledgement of the Department’s action.

For further information on the Board Rules, you can refer to 4 Colorado Code of Regulations (CCR) 801-1, State Personnel Board Rules and Personnel Director's Administrative Procedures, Chapter 8, Resolution of Appeals and Disputes, atspb.colorado.gov/board-rules.

.A complete application packet must include:

1. A completed State of Colorado application.

2. If using education to qualify, a copy of your college/university transcripts. Transcripts must be attached to your colorado.gov/jobs application.

3. If you are a veteran, a copy of your DD214 attached to your colorado.gov/jobs application.

The Selection Process:

1. All applications that are received by the closing of this announcement will be reviewed against the Minimum Qualifications in this announcement. Candidates who meet the minimum qualifications proceed to the next step.

2. Colorado Revised Statutes require that state employees are hired and promoted based on merit and fitness through a comparative analysis process.

   • Part of, or all of, the comparative analysis for this position may be a structured application review, which involves a review of the information you submit in your application materials by Subject Matter Experts (SMEs) against the preferred qualifications.

3. A top group, up to six candidates, will be invited to schedule an interview with the hiring manager.

E-Verify:  CDPHE uses e-Verify, an Internet-based system, to confirm the eligibility of all newly hired employees to work in the United States. Learn more about E-Verify, including your rights and responsibilities.

You must be legally eligible to work in the United States to be appointed to this position. CDPHE does not sponsor non-residents of the United States.

ADAAA Accommodations:
The State of Colorado believes that equity, diversity, and inclusion drive our success, and we encourage candidates from all identities, backgrounds, and abilities to apply. The State of Colorado is an equal opportunity employer committed to building inclusive, innovative work environments with employees who reflect our communities and enthusiastically serve them.  Therefore, in all aspects of the employment process, we provide employment opportunities to all qualified applicants without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity or expression, pregnancy, medical condition related to pregnancy, creed, ancestry, national origin, marital status, genetic information, or military status (with preference given to military veterans), or any other protected status in accordance with applicable law. The Colorado Department of Public Health and Environment is committed to the full inclusion of all qualified individuals. As part of this commitment, our agency will assist individuals who have a disability with any reasonable accommodation requests related to employment, including completing the application process, interviewing, completing any pre-employment testing, participating in the employee selection process, and/or to perform essential job functions where the requested accommodation does not impose an undue hardship. If you have a disability and require reasonable accommodation to ensure you have a positive experience applying or interviewing for this position, please direct your inquiries to our ADAAA Coordinator at cdphe_benefits@state.co.us.