BLS Laboratory Quality Assurance Specialist

University of New Orleans•Baton Rouge, LA

52d

About The Position

Oversees all aspects of quality assurance and compliance with applicable regulations and standards for pre-analytical, analytical, and post-analytical processes, which includes internal audits; interactions with laboratory testing personnel, supervisors, and managers. Provides written reports of all audits, including deficiencies/findings and recommendations, to responsible parties within 30 days of completing the audit, unless extenuating circumstances arise. Revises, reviews, and/or approvals laboratory policies, procedures, quality assurance manuals, and other documentation. Verifies that required employee qualifications, initial demonstration of competence, and ongoing training/competency are completed and recorded. Reviews and/or approves verification/validation of new test methods. Prepares for, facilitates, and responds to on-site audits for agencies certifying or accrediting testing performed by the Office of Public Health (OPH) Bureau of Lab Services (BLS) or public health unit laboratories. Reports any deviations from approved protocols to supervisors, management, and leadership. Institutes and monitors corrective actions (e.g. developing new or implementing changes processes/procedures) in collaboration with laboratory supervisors, managers, safety officer and laboratory directors. Oversees the OPH BLS or public health unit laboratories compliance and document control system(s), ensuring document control of all documents is established, maintained, and ensuring accessibility of current revisions/versions of all necessary documents. Provides basic training and continuing education to laboratory staff and submitters statewide regarding issues that affect specimen testing, transport and result reporting. Participates in meetings related to compliance and/or quality assurance issues. Coordinates with laboratory managers and supervisors to ensure that all proficiency testing is performed in compliance with applicable regulations and standards. Maintains compliance with federal and state laws and regulations and ensures the retention and protection of laboratory data at all times. Maintains awareness and understanding of laboratory safety and security including following good chemical hygiene practices when handling samples and chemical reagents. Reports unsafe conditions to the laboratory supervisor. Other tasks as assigned.

Requirements

Bachelor’s degree.
Minimum 3 years professional experience working in a biological laboratory, chemical laboratory or environmental laboratory.
Minimum 1 year professional experience with laboratory quality assurance.
Must have a valid Clinical Laboratory Scientist Generalist (CLS-G) or Clinical Laboratory Scientist (CLC-S) license issued by the Louisiana State Board of Medical Examiners.
Excellent analytical and critical thinking skills; effective organizational and time management skills.
Great attention to detail and follow up.
Ability to manage projects, assignments, and competing priorities.
Proficient in the use of Zoom, Teams, and Microsoft Office, including but not limited to Outlook, Word, and Excel.

Nice To Haves

Advanced degree.
Minimum 4 years professional experience working in a biological laboratory, chemical laboratory or environmental laboratory.
Minimum 2 years professional experience with laboratory quality assurance.
Minimum 2 years professional experience working within a public health care setting.
Relevant industry certifications.

Responsibilities

Oversees all aspects of quality assurance and compliance with applicable regulations and standards for pre-analytical, analytical, and post-analytical processes, which includes internal audits; interactions with laboratory testing personnel, supervisors, and managers.
Provides written reports of all audits, including deficiencies/findings and recommendations, to responsible parties within 30 days of completing the audit, unless extenuating circumstances arise.
Revises, reviews, and/or approvals laboratory policies, procedures, quality assurance manuals, and other documentation.
Verifies that required employee qualifications, initial demonstration of competence, and ongoing training/competency are completed and recorded.
Reviews and/or approves verification/validation of new test methods.
Prepares for, facilitates, and responds to on-site audits for agencies certifying or accrediting testing performed by the Office of Public Health (OPH) Bureau of Lab Services (BLS) or public health unit laboratories.
Reports any deviations from approved protocols to supervisors, management, and leadership.
Institutes and monitors corrective actions (e.g. developing new or implementing changes processes/procedures) in collaboration with laboratory supervisors, managers, safety officer and laboratory directors.
Oversees the OPH BLS or public health unit laboratories compliance and document control system(s), ensuring document control of all documents is established, maintained, and ensuring accessibility of current revisions/versions of all necessary documents.
Provides basic training and continuing education to laboratory staff and submitters statewide regarding issues that affect specimen testing, transport and result reporting.
Participates in meetings related to compliance and/or quality assurance issues.
Coordinates with laboratory managers and supervisors to ensure that all proficiency testing is performed in compliance with applicable regulations and standards.
Maintains compliance with federal and state laws and regulations and ensures the retention and protection of laboratory data at all times.
Maintains awareness and understanding of laboratory safety and security including following good chemical hygiene practices when handling samples and chemical reagents.
Reports unsafe conditions to the laboratory supervisor.
Other tasks as assigned.