Quality Assurance Scientist

About This Role

The Quality Assurance Scientist contributes to the State Public Health Laboratory's mission by developing and maintaining a comprehensive QA Program, ensuring the highest quality of service and regulatory compliance.

Responsibilities

• Ensure highest possible quality of service through development and maintenance of a comprehensive QA Program
• Track regulatory compliance of ISO 17025:2017, FDA, CLIA and EPA regulations
• Perform internal QA audits and make recommendations to resolve quality issues and improve efficiencies
• Serve as subject matter expert for ISO 17025:2017, FDA and EPA requirements in the Quality Management System (QMS)
• Maintain the iPassport regulatory compliance software system
• Document and maintain records to ensure staff compliance with agency quality management system and statutory requirements
• Provide cross-training to staff for Quality Assurance Functionality
• Solicit input on training topics, facilitate access to continuing education, and track CE for division staff

Requirements

• 5+ years of relevant experience in a laboratory setting performing biological, microbiological, biochemical or molecular science testing with an emphasis on directing or designing QA protocols and safety procedures.

Qualifications

• A combination of related education in biological and/or physical science and/or relevant experience equal to five (5) years
• 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.

Nice to Have

• Advanced degree in biological and/or physical science
• Ability to collaborate and achieve consensus across work units and programs
• Knowledge of generally accepted laboratory QA/QC procedures and processes
• In-depth knowledge of laboratory regulatory requirements (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
• 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

Skills

* Required skills

Benefits