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State of Colorado · 1 day ago

CDA-Senior Quality Assurance Analyst (Physical Scientist III).

Broomfield County, CO

Full-time

Onsite

Senior Level

$88K/yr - $106K/yr

6+ years exp

The State of Colorado is committed to supporting its agricultural industry and is seeking a Senior Quality Assurance Analyst to ensure compliance with national and international standards in laboratory services. The role involves administering the Quality Assurance Program, conducting internal audits, and overseeing quality control processes within the Biochemistry Laboratory.

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Responsibilities

Coordinate and administer 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

Ensure 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)

Implement required quality elements in close consultation with laboratory operations management and proactively recommend 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

Review, examine, inspect, and/or evaluate 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

Perform 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. Oversee internal audits conducted by others and ensure that the audit conduct and reporting meets internal and external standards and requirements. Provide a full report of all audit findings and suggest 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

Coordinate BCL calibration of devices such as weight sets, thermometers, pipettes, dispensers, balances, timers, etc. with external calibration firms

Support operation and maintenance of the BCL Laboratory Information Management System (LIMS). 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

ISO/IEC 17025Quality AssuranceQuality ControlLaboratory Information Management SystemProficiency TestingRisk AnalysisStandard Operating ProceduresInterpersonal SkillsCommunication SkillsProblem-Solving

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!