732-661-0400

Senior Compliance Specialist

  • Location: Woodstock, GA
  • Type: Direct Hire
  • Job #35472

Leading company for laboratory setup and management hiring for a Senior Compliance Specialist.

 

As a Senior Compliance Specialist, you will be responsible for maintaining compliance policies and procedures, including training and education, performing audits and investigation incidents, maintaining accreditation documentation and reports. As a successful Senior Compliance Specialist, will demonstrate a documented record of participation in clinical laboratory audits and strong foundational skills in the application of laboratory compliance. You will have your ASCP, AMT, ABB, or NCA State Certifications, as well as 6+ years of experience in a high complexity lab and QC Review, as well as a Bachelor’s Degree. This role is perfect for talent that is eager to progress in their field of laboratory compliance, and is open to traveling anywhere from 25-50% of the time to perform onsite compliance audits.

 

Requirements:

  • Bachelor’s degree in science and six years; Master’s degree in science and four years; or Ph.D. in science and two years of laboratory training or experience in high complexity testing for the subspecialties of Toxicology and Microbiology/Molecular biology.
  • Qualify as a technical supervisor as it pertains to CLIA standard 42CFR 493.1449.
  • Uphold the confidentiality of all patient-related information (PHI).
  • Responsible for creating and coordinating training and competency assessments as required for laboratory testing, safety, quality, and compliance regulations.
  • Responsible for developing a culture that recognizes quality assurance as an essential part of the organization.
  • Can handle difficult, sensitive, and confidential situations with integrity and tact.

Key Duties:

  • Ensure compliance with regulatory agencies standards such as (CAP, COLA, CLIA, TJC), as well as guarantee high levels of quality assurance/quality control practices and take responsibility for evaluating, developing, and the execution of the laboratory safety program, as well as work with laboratories to ensure activities are compliant with regulatory agencies’ standards.
  • Collaborate with directors, managers, clinicians as well as other healthcare professionals (lab and non-lab testing personnel) executing and advancing established departmental goals.
  • Ability to meet the responsibilities of the Technical Supervisor Job responsibilities as it pertains to CLIA standard 42 CFR 493.1451. (The technical supervisor is responsible for the technical and scientific oversight of the laboratory. The technical supervisor is not required to be on site at all times testing is performed; however, he or she must be available to the laboratory on an as needed basis to provide supervision.
    • The technical supervisor must be accessible to the laboratory to provide on-site, telephone, or electronic consultation; and
    • The technical supervisor is responsible for –
      1. Selection of the test methodology that is appropriate for the clinical use of the test results.
      2. Verification of the test procedures performed and establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system;
      3. Enrollment and participation in an HHS approved proficiency testing program commensurate with the services offered;
      4. Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results;
      5. Resolving technical problems and ensuring that remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications;
      6. Ensuring that patient test results are not reported until all corrective actions have been taken and the test system is functioning properly;
      7. Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed;
      8. Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to –
    • Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing;
    • Monitoring the recording and reporting of test results.
    • Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records.
    • Direct observation of performance of instrument maintenance and function checks.
    • Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and
    • Assessment of problem-solving skills; and evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. Thereafter, evaluations must be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation.
  • Handle Logs, files, and organize correspondence/tasks for compliance audits.
  • Work together with other compliance department personnel to perform risk management for compliance audits.
  • Responsible for preserving compliance related policies and procedures.

 

**This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you**

 

 

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Equal Employment Opportunity (EEO) Information

While the position you're applying for may not be for a government role, Astrix is a governmental contractor and, as such, is required to collect certain information in its applicants. Astrix is an Equal Opportunity Employer and does not discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status. Completion of these fields will not affect your opportunity for employment or the terms or conditions of your employment.

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