Scientific Lab Director- PerkinElmer Genetics

JOB SUMMARY:

The Scientific Lab Director reports to the either the VP & CSO PerkinElmer Genetics, Global Laboratory Services and is responsible for implementing new assays, assay trouble-shooting, participating in QA/ QC responsibilities, providing technical support to operations staff, and reviewing and approving SOPs. Additional responsibilities include technical interpretation of genetics results, signing reports, and providing consultations with physicians regarding technical aspects of assays. The Scientific Director may also serve as the back up for the Director of Laboratory Testing and Clinical Education. Assumes Clinical Consultant or Technical Supervisor responsibilities as assigned by the VP & CSO of global laboratory services.

JOB RESPONSIBILITIES:

1. Interpret results of clinical genetic testing.

2. Assist in assay trouble-shooting and implementation of new assays.

3. Monitor compliance in regards to a safe working environment.

4. Assist, as needed, in the training of technologists.

5. Observe compliance with regulatory agencies, including inspections.

6. Monitor quality assurance at all levels of practice.

7. Participate in working groups of related or associated professional societies and regulatory agencies.

8. Technical consultation with operations staff.

9. Approval of test method selection, design, and validation.

10. Ensure that the proficiency testing program is conducted in a timely manner and reviewed by appropriate staff, and approval of corrective action when a proficiency testing result is found to be unsatisfactory.

11. Establish and monitor quality control to ensure that acceptable levels of analytical performance are maintained for each test system. Ensure that patient test results are reported only when the system is functioning properly.

12. Approve all corrective action and preventative action plans and procedure.

13. Annually review/approve Standard Operating Procedures for test systems.

14. Consult, as needed, with physicians and other customers regarding genetic testing.