Manager, Quality Assurance

Job Description

Lead, support and coordinate efforts that foster quality and ensure that all pre-analytical, analytical and post-analytical processes are consistent with our company values and mission. 

Work Schedule: Hybrid (3 days Onsite, 2 days from Home)

Pay Range: $103,000 - $143,000/ year, 10% Annual Incentive Plan/Bonus

Salary offers are based on a wide range of factors including relevant skills, training, experience, education, and, where applicable, certifications obtained. Market and organizational factors are also considered. Successful candidates may be eligible to receive annual performance bonus compensation.

Benefits Information:

We are proud to offer best-in-class benefits and programs to support employees and their families in living healthy, happy lives. Our pay and benefit plans have been designed to promote employee health in all respects – physical, financial, and developmental. Depending on whether it is a part-time or full-time position, some of the benefits offered may include:

· Medical/Prescription Drugs

· Dental

· Vision

· Flexible Spending Accounts (FSAs)

· Supplemental Health Plans

· 401(k) Plan – Company match dollar-for-dollar up to 5%

· Employee Stock Purchase Plan (ESPP)

· Supplemental Life Insurance

· Dependent Life Insurance

· Short- and Long-Term Disability buy-up

· Blueprint for Wellness

· Emotional Well-Being Resources

· Educational Assistance 

Responsibilities:

Leadership  

• 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. 

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. Proficiency Testing Identify all tests performed and ensure enrollment and participation in external proficiency testing for each test. For those tests not covered by external proficiency testing, ensure internal proficiency testing is performed. Ensure that all proficiency testing is reviewed and corrective action is complete for all non-conformances.  
• Ensure that a Validity Check program is in place, as well as a Blind Samples resubmission program, if applicable.  
• Ensure that a defined instrument to instrument, method to method, and laboratory to laboratory comparison process, with fixed criteria for accessing acceptability, is performed and documented at least semi-annually. 

 

Quality Assurance/Quality Improvement  

• Conduct monthly QA meetings with required participation by all areas (including RRLs and Metro Laboratories) having an impact on pre-analytical, analytical and post-analytical phases of testing (exception Billing).  
• Create effective materials (e. g., graphs, charts) to promote Quality Improvement (QI) and present plans and results at monthly meetings.  
• Ensure that each department has a comprehensive Quality Improvement plan with monitors and that each department communicates their metrics and implements appropriate actions.  
• Develop, monitor and improve Quality Assurance specif