Quality Assurance Scientist (PSRSI). jobs in United States
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Colorado Department of Public Health and Environment · 14 hours ago

Quality Assurance Scientist (PSRSI).

The Colorado Department of Public Health and Environment is dedicated to advancing Colorado's health and protecting the community. The Quality Assurance Scientist will support the laboratory's mission by ensuring high-quality service through the development and maintenance of a comprehensive QA Program, tracking regulatory compliance, and performing internal audits.

Health Care
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Responsibilities

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
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
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
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

Qualification

ISO 17025 2017FDA regulationsCLIA regulationsEPA regulationsQuality Assurance protocolsInternal QA auditsLaboratory regulatory complianceDocument controlManagement skillsCommunication skillsCritical thinkingInterpersonal skillsAttention to detail

Required

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
A combination of related education in biological and/or physical science (e.g., microbiology, molecular biology, chemistry or genetics) and 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
A copy of your transcripts must be submitted at the time of application. Unofficial transcripts are acceptable. Late transcripts will not be accepted
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
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
On-site position

Preferred

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

Benefits

Free parking
Access to RTD bus lines
Cherry Creek bike path
Flexible working arrangements

Company

Colorado Department of Public Health and Environment

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Do you have a passion and drive to apply your talent to create a better Colorado? Are you looking for a career that provides you with opportunities to improve the world around you? Our mission is to protect and improve the health of Colorado's people and the quality of its environment.

Funding

Current Stage
Late Stage
Total Funding
unknown
Key Investors
Caring for Denver Foundation
2022-07-28Grant
2021-06-11Grant

Leadership Team

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Alex Barba
Chief of Staff and Chief Operating Officer, Disease Control & Public Health Response Division
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Amber Schwab
Executive Assistant To Chief Executive Officer
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