Laboratory Compliance Officer (PSRSI)

Division of Disease Control and Public Health Response

This requires Colorado Residency to apply

This is a hybrid 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.

The following information aims to provide potential candidates with a better understanding of the requirements for this role.

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, click the link below to review additional benefits and perks!!! https : / / cdphe.colorado.gov / careers

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.

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.

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.

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.

Residency Requirement :

This posting is only open to residents of the State of Colorado at the time of submitting your application.

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.

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) years.

Preferred Qualifications and Essential Competencies :

• 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

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.
• Hybrid position and will require time on-site that is determined by the division / manager.
• Ability to travel 50% of the time to perform inspections alone.

Appeal Rights :

An applicant who has been removed from an employment list or removed from consideration during the selection process may request a review by the State Personnel Director.

The Selection Process :

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.

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.

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.

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