Specialist, Quality Assurance

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 / Techniques
• CLIA, 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