Laboratory Compliance Officer

The Division of Disease Control and Public Health Response (DCPHR) exists to ensure that the Department has the ability to effectively monitor, detect, diagnose, prepare for, and nimbly respond to, all types of conditions and events that impact the public’s health. 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, Technology Branch; 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 Unit: 
 The program serves as the official State Agency (SA) contact, regulatory authority and certification body for various laboratory types to include medical/diagnostic, environmental, dairy, forensic toxicology, marijuana, hemp, and natural medicine testing labs. The program establishes standards of performance for forensic toxicology, hemp, and natural medicine laboratories which are promulgated through Colorado Board of Health Rules.
 
 What you will be doing: 
 The position exists to evaluate and determine compliance with state cannabis and natural medicine lab regulations and best practices. This position exists to support the cannabis and natural medicine lab certification section and facilitate the inspection process which includes the following duties:
 
 Laboratory Inspection

• Work in coordination with other lab certification section staff to ensure timely and high quality inspection processes.  
• Review and verify information in applications and other documents for adequacy to recommend accepting or denying inspection requests submitted by testing facilities.
• Apply scientific theory, technical knowledge and expertise, and regulatory standards in diverse facilities to detect technical deficits, regulatory violations, or failure to comply with approved policies.
• Apply good laboratory practices in conjunction with effective interview and data collection methods to perform annual onsite inspections of testing facilities.  
• Write reports, collect and evaluate plans of correction and recommend issuance, suspension, or revocation of certification to supervisor.
• Work collaboratively with other State Departments and Divisions.

Quality Assurance/Quality Control

• Assess testing facilities on their compliance with regulations in regards to quality.

Analytical Testing

• Interpret complex scientific analyses and apply this knowledge to the assessment of testing facilities for compliance with regulations. For example:  
  • Specimen receipt and preparation  
  • Laboratory testing and proficiency testing.  
  • Evaluation of testing results for quality control purposes.   
  • Troubleshooting

Instrumentation

• Assess testing facilities on their operation, calibration and maintenance of equipment used in quantitative and qualitative analysis.  
• This position must evaluate if testing facilities have established appropriate criteria for instrument performance.

Method Development & Validation

• Assess testing facilities on their compliance with regulations pertaining to method development and validation. This position must evaluate if testing facilities have established and demonstrated appropriate criteria for method performance.

Residency Requirement:
 This posting is open to current and non-current residents of the State of Colorado at the time of submitting your application. However, if you are selected and accept the position, you will be required to establish residence in the State of Colorado.
 
MINIMUM QUALIFICATIONS: 
Experience: 
 Six (6) years of professional experience* in a laboratory setting conducting quality assurance/control, performing testing and/or conducting inspections/audits for regulatory compliance, preferably in the cannabis, pharmaceutical, food, or clinical industry.
 
 OR 
 
Education and Experience:

A combination of related education** from an accredited institution in chemistry, biology or closely related degree and/or relevant experience* in a laboratory setting conducting quality assurance/control, performing testing and/or conducting inspections/audits for regulatory compliance, preferably in the cannabis, pharmaceutical, food, or clinical industry that equals to six (6) years.

*This 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 transcripts must be submitted at the time of application.  Unofficial transcripts are acceptable. Late transcripts will not be accepted. 

 Preferred Qualifications and Essential Competencies:
Relevant years of State service contribute to a candidate's position-related knowledge, skill, ability, behavior or other posted competency should be considered as a preferred qualification and given weight under the process.

• Previous experience in laboratory inspections/audits, quality assurance/control, or regulatory compliance, preferably in the cannabis, pharmaceutical, food, or clinical laboratory industry.
• Experience with analytical testing techniques and instrumentation.
• Understanding and familiarity with method development and validation processes and principles.
• Strong understanding of scientific principles and laboratory practices.
• Knowledge of state cannabis and natural medicine regulations, or the ability to quickly acquire this knowledge.
• Proficiency in interpreting complex scientific analyses.
• Excellent analytical and problem-solving skills.
• Strong communication skills, both written and verbal, for writing reports and conducting interviews.
• Attention to detail and ability to ensure compliance with regulatory standards.
• Proficiency in using laboratory equipment and software for data analysis.
• Ability to assess the operation, calibration, and maintenance of laboratory instrumentation.
• Ability to build and maintain professional relationships with stakeholders.
• Diplomacy and tactfulness in dealing with potentially sensitive or contentious situations during inspections.
• Familiarity with state and possibly federal regulations pertaining to cannabis and natural medicine labs.
• Understanding of good laboratory practices (GLP) and other relevant regulatory standards.
• Ability to work effectively in a team and independently.
  

Must be willing to: 

• Pre-employment background check
• Travel to conferences
• Travel to inspections
• Relocate to Colorado. 
• 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.
• 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.

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.

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, at spb.colorado.gov/board-rules.

A complete application packet must include:

1. A completed State of Colorado application.

2. A cover letter that describes how your experience aligns with the minimum and preferred qualifications of this position. 

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

4. 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, Dan McKenna, at daniel.mckenna@state.co.us or call 303-692-2060, option 5.

Salary : $67,668 - $74,436