Manager, Quality Assurance

Lead, 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

• A direct advocate for quality and enable quality processes throughout scope of work.
• Ensure accountability within all areas of the business unit (pre-analytical, analytical and post-analytical, scope) such that every employee consistently exhibits behavior that promotes and supports quality.
• Supply positive and encouraging influence both directly and indirectly through laboratory management such as directors, department managers, supervisors and quality assurance teammates.
• Ensure accountability within the Main Laboratories (aka Business Units / BUs), Rapid Response Laboratories (RRLs) and Patient Service Centers (PSCs) as needed, such that employees consistently exhibit behavior that produces high quality outcomes.
• Encourage continuous improvement and continuing education, including quality and quality control subject matter.

2) Licensing and Accreditation

• Direct the internal inspection process of BUs, RRLs and Patient Service Centers 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 and ensure laboratory compliance. Serve as a resource regarding laboratory standards and regulations (i.e., CLIA, CAP, CDPH, etc.) for all locations.
• Ensure all testing facilities and personnel have appropriate licensure and certifications as required by federal, state, and local regulations.Where applicable, ensure that CAP accreditation remains in good standing.
• Collaborate with BU management on any projects and responsibilities deemed beneficial to the laboratory.
• 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 proficiency testing is completed according to Quest Diagnostics' policy and procedures within timeline.
• Ensure that the CLIA required instrument to instrument, method to method, and laboratory to laboratory comparison process, is performed correctly and documented at least semi-annually as well as all other instrument and process related requirements.

3) Quality Assurance / Quality Improvement

• Conduct monthly / periodic QA meetings with required participation by all areas (including RRLs and BU labs) 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 for QA teams and other meetings.
• Ensure that each department has a comprehensive QMP and Quality Improvement plan with monitors and that each department communicates their metrics and implements appropriate actions at each defined timeline.
• Develop, monitor and improve Quality Assurance specific quality indicators, including but not limited to: Reportable Quality Issues, Proficiency Testing outcomes, Revised Reports tracking, and performance on inspections.
• Ensure all laboratory Policies/SOPs/Forms are under document control and receive biannual review.
• Resolve customer complaints and investigations regarding any pre-analytical, analytical, and post- analytical issue.

4) Quality Control

• Act as a contact for the national Quality Control (QC) peer comparison programs and ensure enrollment and effective corrective action as appropriate.
• Ensure performance of required Corporate Quality Surveillance Program, Patient Results Distribution Program, Best Practice Team Initiative/Database Changes Verification Program and other monitoring programs specifically assigned by the National Quality Assurance Team (MOQ).

5) Quality Assurance Initiatives

• Ensure all laboratory duties are appropriately delegated by the laboratory director as required by applicable federal, state and local regulations.
• Ensure that all departments have a process to identify and evaluate the relationship of patient information to patient test results.
• Ensure prompt and complete reporting of patient test results.
• Seek and review opportunities for quality improvement. Review options with laboratory leadership and QA team.

Required Work Experience:

• Minimum 4 years of Clinical Laboratory Experience
• Minimum 2 years of Quality Assurance and/or Quality Control and/or Regulatory Affairs Experience (can be included in Clinical Laboratory Experience)

Preferred Work Experience:

• 4 years of Quality Assurance Role as a Specialist, Manager or Director

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 and CLIA, CAP, Quality Assurance Standards

Skills:

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

EDUCATION
Bachelor's degree (required), scientific disciplines

Associate's degree (required), for MLT to CLS candidates

LICENSE CERTIFICATIONS
Certification / Qualification as General Laboratory Supervisor as defined by CLIA '88

CDPH CLS (Generalist or Limited/Specialist) License, must be current and effective

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