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<div class="isg-job-description“>Job Description
This position assesses quality activities for all Quest Diagnostics laboratories by, primarily, performing Quality Assessments to ensure compliance with regulatory standards and Quest policies.
Responsibilities:
- Conduct and/or lead internal inspections of Quest Diagnostics domestic and international laboratories. This includes the following: Esoteric laboratories, Regional laboratories, AmeriPath Diagnostics, Quest hospital laboratories (QHLs), rapid response laboratories, joint venture laboratories, point of care testing and contracted laboratories.
- Compose and submit timely and accurate inspection reports for corresponding inspections.
- Manage inspection responses to ensure completeness and accuracy.
- Maintain knowledge of laboratory regulatory requirements, to include accrediting bodies, federal, state, and local requirements as well as Quest Diagnostics policies.
- Represent MQA on various company teams/groups related to laboratory testing.
- Provide communication to the laboratories on relevant quality issues.
- Collaborate with National Laboratory Operations and Business Transformation teams.
- Serve as a resource and subject matter expert (SME) to laboratories for quality and regulatory issues.
- Participate in quality monitoring activities for Clinical Pathology, as required (e.g., metrics, Proficiency Testing (PT), CAP educational surveys, CAP, RQI, etc.).
- Prepare written communications and deliver presentations to laboratories, as required.
- Provide on-site consultation on quality and/or regulatory issues.
- Support and participate in special company-wide projects etc.
- Participate in annual continuing education and company training, as designated.
- Comply with all Quest Diagnostics policies including, but not limited to:
- Employee Handbook
- “Your Compliance Policy Handbook”
Qualifications:
Required WorkExperience:
- Three (3) years-experience in a laboratory, including leadership responsibilities – required
- Three (3) years-experience in laboratory quality assurance/quality control activities, including laboratory regulations/accreditation requirements – required
- Experience managing a laboratory department, to include pre-analytic, analytic and post analytic QA/QC activities.
- Graduate of NCCLS approved program or equivalent education.
Preferred Work Experience:
- Supervisory and work experience in clinical Molecular testing. Skills preferred: DNA sequencing, PCR, extraction.
- Hospital work experience
- Experience conducting CAP or other regulatory audits
Physical and Mental Requirements:
- Maintain composure under pressure
- Adapts to change
- Ability to grasp information quickly
- Ability to multi-task
- Using effective verbal communication
- Using effective written communication
- Handle stress & emotions
- Making decisions
- Examine/observe details
Skills:
- Proficient in Microsoft Word, Excel, Outlook, PowerPoint etc.
- Possesses excellent communication (verbal and written), influencing, and collaboration skills
- Ability to work independently and effectively plan/organize work and projects
- Demonstrate team building and problem-solving skills
Education
- Bachelor’s Degree – Major: Chemical, Biological, or Clinical Laboratory Science or Medical Technology (Required)
Licenses and Certifications
- ASCP Specialist Certification (Preferred)
- ASCP Medical Laboratory Scientists (MLS) (Preferred)
- Clinical Laboratory Scientist (CLS) (Required)
- Six Sigma Certified Green Belt (Preferred)
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Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets or any other legally protected status.
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