Mgr, Med Quality, Mol Gen- San Juan Capistrano, CA req53968 in San Juan Capistrano, CA at Quest Diagnostics

Date Posted: 11/6/2020

Job Snapshot

Job Description

Mgr, Med Quality, Mol Gen- San Juan Capistrano, California - Mon-Fri

Look for more than answers. Patients and Physicians rely on our diagnostic testing, information and services to help them make better healthcare decisions. These are often serious decisions with far reaching consequences, and require sensitivity, tact and a clear dedication to service. It’s about providing clarity and hope. 

You will work for the world leader in the industry, with a career where you can
expand your skills and knowledge. You’ll have a role where you can act with
professionalism, you can inspire colleagues, and you can care about the work we do and the people we serve. 

At Quest, we are on a continuous journey of discovery and development. It’s this attitude that has made us an industry leader and the #1 Diagnostic Lab in the US. For those joining us, we offer exciting and fast moving career opportunities where you can affect change at a rate unheard of in many organizations of our size and scope. While we invest in and develop technology to drive our innovations, our ongoing success relies on our people.

Basic Purpose:

Evaluation of testing assays for the appropriate laboratory discipline / testing category to identify and mitigate risk.

Duties and Responsibilities:

  • Evaluate the development and deployment of testing assays for the appropriate laboratory discipline / testing category.
  • Review / approval of standard operating testing procedures prior to issuance for implementation to help ensure accuracy of testing.
  • Conduct pre-go-live inspections to identify and mitigate risk including but, not limited to: SOP review for practice matching procedure; review of method validation; observation of entire testing process to evaluate the robustness of the assay; appraisal of Quality Control (QC) metrics for sufficient level of acceptability; and technologist interviews and observation on how to address assay issues for out of range QC measures (e.g., out of range QC, assay interference).
  • Investigate quality issues identified within Quest Diagnostics laboratories for the appropriate laboratory discipline / testing category (e.g., quality investigations) and facilitate problem resolution.
  • Act at the direction of Corporate Legal as required.
  • Interface with the discipline’s Clinical Franchise to identify high-risk assays for evaluation.
  • Collaborate with National Laboratory Operations and other Quest Diagnostics functions to meet desired outcomes.
  • Support implementation for assays across Quest Diagnostics facilities. 
  • Mediate discussions between subject matter experts regarding testing and test systems.
  • Support the development and deployment of standard quality assessment policies and programs.
  • Utilize quality management reports and metrics as required. (e.g. CAP, RQI, PRDP)
  • Maintain knowledge of laboratory regulatory requirements, to include accrediting bodies, federal, state, and local requirements as well as Quest Diagnostics policies.
  • Prepare written communications and deliver presentations as required.
  • Provide technical and consultative support to Laboratory Staff and Quality Assurance Departments.
  • Assist in special projects and activities as required.
  • Apply the Quest Management System approach for daily work and project management.
  • Travel 30-50%, as needed.

Supervision Exercised:

  • If applicable, manage any assigned employee(s) reporting to this position

Qualifications:

Education Preferred:  

  • Bachelor’s Degree in a Life Science or related field required
  • Master’s degree preferred
  • Certification by American Society for Clinical Pathology Board of Registry (ASCP) – desired
  • Certification by American Society for Quality (ASQ) - desired

Work Experience:     

  • At least eight years successful employment in a clinical /pathology laboratory environment – required
  • Experience in working effectively in an FDA-regulated environment - preferred
  • Experience with quality management system development – required
  • Physical and Mental Requirements:          
  • Prolonged sitting at a desk (i.e., operating a computer, telephone use, document review)
  • Walking or standing within the office area to operate other office equipment (i.e. printer / fax) or within the laboratory
  • Required to wear PPE as appropriate when visiting testing locations
  • Must frequently respond to text/email communications and will be required to be aware of ergonomic principles
  • May be required to travel by airplane /train or drive long distances
  • Ability to follow verbal or written instructions and use effective verbal and written communication

Other:

  • Competencies
  • Demonstrated ability to influence and create change – required
  • Strong interpersonal communication skills – required
  • Demonstrated strong writing and composition skills – required
  • Demonstrated success in motivating team members to reach objectives – desired
  • Business Process Skills
  • Able to effect Quality Improvement through problem solving skills and knowledge of quality tools – required
  • Able to lead and drive change – required
  • Organization skills--required
  • Project and team management skills – required (Quest Management System skills – preferred)
  • Analytical and problem solving skills – required
  • Computer skills, including standard business software tools and typing – required
  • Able to function in a matrix organization—desired
  • Multi-tasking skills—desired
  • Flexibility to meet continuously changing priorities and challenges



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