Manager, Quality Assurance
Responsibilities
Direct, advocate for and enable visibility of quality processes.
Ensure accountability within all areas of the business unit (pre-analytical, analytical and post-analytical) such that every employee consistently exhibits behavior that promotes and supports quality.
Influence may be exerted both directly and indirectly through the management of liaisons and intermediaries, such as department managers and supervisors as well as members of the Quality Assurance (QA) Committee.
Direct, advocate for and enable visibility of quality processes.
Ensure accountability within the Rapid Response Laboratories (RRLs) and Metro Laboratories of the business unit (pre-analytical, analytical and post-analytical) such that every employee consistently exhibits behavior that promotes and supports quality.
Influence may be exerted both directly and indirectly through the management of liaisons and intermediaries, such as Medical Directors, managers or supervisors.
Requirements
Licensing and Accreditation
- Direct internal inspection process of the business unit, associated laboratories and specimen collection sites to ensure compliance with applicable federal, state, and local regulations, College of American Pathologists (CAP) accreditation requirements and Quest Diagnostics standards.
- Review and ensure that corrective action is implemented when non-conformances are found.
- Monitor published guidelines for revisions to regulations and/or accreditation standards and ensure laboratory compliance.
- Serve as a resource regarding Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) regulations and CAP accreditation standards for all sites.
- Ensure all testing facilities/personnel have appropriate licensure and accreditation as deemed by federal, state, and local regulations.
- Collaborate with business unit management even if primary responsibility has not been assigned to QA.
Qualifications
- Work Experience: Min 2 years Quality Assurance experience requiredMin 5 years Quality Assurance experience preferred
- American Society for Quality (ASQ) certification preferred
- Education: Bachelor’s Degree Chemical, physical, biological or clinical laboratory science or medical technology (Required)
- Licenses and Certifications: Certifications Qualification as General Laboratory Supervisor as defined by CLIA '88 (Preferred)