Quality Assurance Scientist (PSRSI)

Full Job Description

Requirements

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.
• Preforms 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 training topics, facilitates access to continuing education for internal and external laboratory staff and tracks continuing education (CE) for division staff to ensure maintenance of staff credentials and state of the art laboratory systems knowledge.

Qualifications

Residency Requirement:

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

MINIMUM QUALIFICATIONS:

Five (5) years of relevant experience* in a laboratory setting performing biological, microbiological, biochemical or molecular science testing with an emphasis on directing or designing quality assurance (QA) protocols and safety procedures.

OR

Education and Experience:

A combination of related education** biological and/or physical science (e.g., microbiology, molecular biology, chemistry or genetics and/or relevant experience* in a laboratory setting performing biological, microbiological, biochemical or molecular science testing with an emphasis on directing or designing quality assurance (QA) protocols and safety procedures equal to five (5) 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.

NOTE: Click on the link here How to Apply to submit a complete application that documents your work history giving details of your qualifications, including how your experience aligns with the minimum and preferred qualifications for this position when listing your work history.

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.

• An advanced degree in biological and/or physical science (e.g., microbiology, molecular biology, chemistry, or genetics)
• Ability to collaborate and achieve consensus across work units and programs
• Knowledge of generally accepted laboratory QA/QC procedures and processes as they apply to diagnostic and/or environmental testing
• In-depth knowledge of laboratory regulatory requirements (e.g., CLIA, EPA, FDA, ISO)
• In-depth knowledge of biosafety recommendations and experience working at BSL-3
• In-depth knowledge of performing internal audits against regulatory compliance.
• In-depth knowledge of chemical safety recommendations
• Excellent management and supervisory skills
• Ability to strategize, organize and plan, including creating and updating training plans
• Ability to effectively communicate both orally and in writing with a wide range of customers
• Knowledge of and use of desktop computer hardware and software
• Excellent critical thinking and problem solving skills
• Excellent interpersonal and customer service skills
• Ability to interpret regulations and statutes
• Ability to interpret and analyze data
• Keen attention to detail
• Ability to self-motivate
• 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. 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.
• On-site position

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.

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.

Additional Information

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.