State of Colorado · 3 hours ago
Quality Assurance Scientist (PSRSI)
Denver, CO
Full-time
Onsite
Senior Level
5+ years expThe State of Colorado is seeking a Quality Assurance Scientist to support the mission of the Division of Disease Control and Public Health Response. This role involves ensuring the highest quality of service in laboratory operations through the development and maintenance of a comprehensive Quality Assurance Program, including regulatory compliance and internal audits.
GovernmentNon Profit
No H1B
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
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
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
Qualification
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. 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
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
State of Colorado
State of Colorado is a non profit organization.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Jeanni Stefanik
Chief Financial Officer
Alan Salazar
Chief Strategy Officer for Colorado Governor John Hickenlooper
Recent News
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