Support and coordinate efforts that ensure excellence and quality in pre-analytical, analytical and post-analytical processes.  Quality efforts must remain consistent with Quest Diagnostics’ company values and mission. 

This is an Onsite position, with flexibility to work on a Hybrid schedule

1) Leadership  

Constant advocate for quality and support the enabling of quality processes throughout scope of work.  Ensure accountability within the laboratory (pre-analytical, analytical and post-analytical, scope) such that employees consistently exhibit behavior that promotes and supports quality. Supply positive and encouraging influence both directly and indirectly through department managers, supervisors and quality assurance teammates. Support continuous improvement, continuing education, including quality and quality control.Engage the Laboratory Director and Operations Leaders to ensure that all objectives are met.

2) Licensing and Accreditation  

Support internal inspection process of BUs, RRLs as needed to ensure compliance with applicable federal, state, and local regulations, College of American Pathologists (CAP) accreditation standards and Quest Diagnostics policy.Review and ensure that corrective actions / preventative actions are implemented when non-conformances are identified. Remain updated on regulations and/or accreditation standards to ensure laboratory compliance.  Serve as a resource regarding laboratory standards and regulations (i.e., CLIA, CAP, CDPH, etc.).Support the establishment and maintenance of facility licensure and certifications as required.  Where applicable, ensure that CAP accreditation remains in good standing.Collaborate with and support BU management on any projects and responsibilities deemed beneficial to the laboratory and support quality objectives.  Proficiency Testing - Identify all tests performed at the laboratory and ensure enrollment and participation in proficiency testing for each test.

3) Quality Assurance / Quality Improvement  

Participate in QA meetings with operations having an impact on pre-analytical, analytical and post-analytical phases of testing (exceptions Billing/Finance/Commercial).  Create effective materials (e. g., graphs, charts, forms, posting) to promote Quality Improvement (QI) and present plans and results.Support each department with their QMP and Quality Improvement plans and help ensure that each department communicates their metrics and implements appropriate actions at each defined timeline. Monitor Quality Assurance specific quality indicators, including but not limited to: Reportable Quality Issues, Proficiency Testing outcomes, Revised Reports tracking, and performance on inspections.  Support document control policy including control of laboratory Policies/SOPs/Forms.Assist with the resolution of customer complaints and investigations regarding any pre-analytical, analytical, and post- analytical issue. 

5) Quality Assurance Initiatives  

Review laboratory duties are appropriately delegated by the laboratory director as required by applicable federal, state and local regulations.  Ensure prompt and complete reporting of patient test results and investigation of errors and client validation requests. Seek and review opportunities for quality improvement.  Review options with laboratory leadership and QA team.

Required Work Experience:  

Minimum 3 years of Clinical Laboratory Experience (as a technologist)Minimum 1 year of Quality Assurance and/or Quality Control and/or Regulatory Affairs Experience (can be included in Clinical Laboratory Experience) 

Preferred Work Experience:  

2 years of Quality Assurance Role as a Coordinator, Specialist or Manager

Physical and Mental Requirements:  

Ability to physically inspect laboratories, travel, and lift approximately 20 lbs.Ability to sit at a workstation and complete computer work for 8 (or more) hours during a work shift.Assess problems effectively, process and calculate best outcomes for challenging situations. 

Knowledge:  

Clinical Laboratory Operations / TechniquesCLIA, CAP, Quality Assurance Standards preferred

Skills:  

Computer systems as a competent user, public speaking, negotiation, diplomacy

Education:

Bachelor’s degree (required), scientific discipline, biological subjects preferred

License Certification:  

Qualification as General Laboratory Supervisor as defined by CLIA '88 Certification by ASCP, as a Technologist  

Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets