Colorado Department of Revenue · 2 days ago
CDA-Senior Quality Assurance Analyst (Physical Scientist III)
Broomfield County, CO
Full-time
Onsite
Mid, Senior Level
$88K/yr - $106K/yr
6+ years expThe Colorado Department of Revenue is committed to advancing Colorado's agriculture and ensuring a safe food supply. They are seeking a Senior Quality Assurance Analyst to oversee the Quality Assurance Program, ensuring compliance with national and international standards in laboratory services.
Government Administration
No H1B
Responsibilities
This duty involves the coordination and administration of the overall Quality Assurance Program (Quality System), with a primary focus on the Biochemistry Laboratory (BCL), and includes participating in quality activities across other Division laboratory units
This role is responsible for ensuring continuous compliance with a complex and evolving regulatory framework, requiring maintained knowledge of ISO/IEC 17025 accreditation requirements; applicable Federal and State regulations; quality mandates from Federal and State grant programs; principles of Good Laboratory Practice (GLP); requirements set by 3rd party accrediting bodies (e.g., A2LA); AOAC quality requirements; and various model regulatory programs (e.g., AAFCO, AAPFCO)
The position implements these required quality elements in close consultation with laboratory operations management and proactively recommends changes to the Quality System to effectively maintain compliance with updated or evolving standards
Develop, write, edit, and facilitate implementation of BCL-wide policies, manuals, standard operating procedures, and work instructions. Design and facilitate implementation of document and records control processes. Administer the laboratory’s Document Control procedures
This position reviews, examines, inspect, and/or evaluates complex scientific and technical data generated from analytical testing activities and research projects. Identify any quality control failures or related deficiencies and assist BCL staff in planning and implementing corrections or corrective actions to address the problems. Monitor corrective actions for effectiveness and close out when satisfactorily completed
This position performs BCL technical and scientific internal audits and surveillances of laboratory activities to ensure compliance with policies, procedures, manuals, program requirements, customer requirements, and/or ISO 17025 accreditation requirements and other regulatory requirements. The position also oversees internal audits conducted by others and ensures that the audit conduct and reporting meets internal and external standards and requirements. This position may assist with internal audits with other laboratory units within the Division as needed. Additionally, this position provides a full report of all audit findings and suggests improvements to address any deficiencies, risks, or other issues identified during the audits
Receive and compile, and track BCL proficiency testing results. Issue and monitor quality corrective actions for any failing results. Assist staff in investigating failures and plan corrective actions
This position coordinates BCL calibration of devices such as weight sets, thermometers, pipettes, dispensers, balances, timers, etc. with external calibration firms
This position supports operation and maintenance of the BCL Laboratory Information Management System (LIMS). Position functions as the primary liaison with the laboratory’s LIMS provider
Prepare written reports, summaries, or data compilations on laboratory activities at the request of the Laboratory Manager, Laboratory Operations Management Team, DLS Division Director, or the Commissioner’s Office
Qualification
Required
Six (6) years of relevant professional QA/QC experience in a regulated laboratory
A combination of related education in Biochemical or Microbiology and/or relevant experience in laboratory setting working with quality assurance equal to Six (6) years
Must be a resident of the state of Colorado
Must be willing to work outside of normal business hours
Excellent interpersonal, communication and public speaking skills
Ability to work in a fast-paced environment and juggle multiple priorities, and able to react and adjust quickly to changing conditions
Unwavering commitment to laboratory impartiality and the ability to identify potential conflicts of interest
Ability to perform risk-based assessments of laboratory processes to prevent non-conforming work
Ability to translate complex regulatory requirements into actionable guidance for bench scientists and non-scientific stakeholders
Superior attention to detail required to maintain the 'Quality Pyramid'
Able to communicate effectively and articulately in writing and orally with diverse communities in all corners of the state
Work well under pressure
Proactive approaches to problem-solving and with strong decision-making capability
Highly resourceful team-player, with the ability to also be extremely effective independently
Preferred
10 years of professional QA/QC experience, specifically within an ISO 17025 accredited environment
Demonstrated knowledge of the ISO/IEC 17025:2017 standard, specifically relating to management requirements and technical competence
Prior experience leading or coordinating an external assessment by an accrediting body (e.g., A2LA, ANAB, etc)
Certification as a quality professional (CQA, CQE, CQM, CQT, etc.) Will be required to obtain it within 12 months of hire
At least two (2) years of experience specifically focused on quality leadership (QA/QC), including experience with risk analysis, root cause analysis, and the implementation of corrective/preventative actions
Proven experience in drafting, reviewing, and approving Standard Operating Procedures (SOPs) and technical validation reports
Experience using laboratory, records management, and data management software (e.g., LIMS systems, SharePoint, NWA control charting and similar systems)
Experience mentoring junior staff and managing Proficiency Testing (PT) programs across multiple disciplines
Experience identifying, evaluating, and mitigating risks to laboratory impartiality and operational validity
Experience calculating Measurement Uncertainty (MU) and establishing metrological traceability
Previous experience in bench chemistry or microbiology working with complex instrumentation (e.g., HPLC MS/MS, QTOF, ICP-OES, PCR, etc.)
Benefits
Strong, secure, yet flexible retirement benefits including a PERA Defined Benefit Plan or PERA Defined Contribution Plan plus optional 401(k) and 457 plans (www.copera.org)
Medical and dental health plans ( https://stateofcoloradobenefits.com/ )
Employer supplemented Health Savings Account ($60 per month)
Paid life insurance, plus additional optional life insurance options
Paid Short Term Disability and optional Long Term Disability coverage
11 paid holidays per year plus generous vacation and sick leave accruals
BenefitHub state employee discount program
Employee Wellness program State of Health
Excellent work-life programs, such as flexible schedules, remote work opportunities, free parking, professional development and more!
Company
Colorado Department of Revenue
With just under 1500 employees, the Colorado Department of Revenue oversees the Division of Motor Vehicles, the Enforcement Division, the Colorado State Lottery, and the Taxation Division.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Lorri Dugan
Chief Financial Officer
Meghan Tanis
Chief Operating Officer/Deputy Executive Director
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