Clinical Laboratory Oversight

We are looking for a part-time Clinical Laboratory Oversight to join us in Turku.

Job purpose:

Be responsible for the medical oversight of the clinical laboratory activities as specified by the by the requirements of ISO 15189, and other local requirements.

Duties and Responsibilities:

• Ensure that laboratory test systems provide quality laboratory services in the pre-analytic, analytic, and post-analytic phases of testing.
• Ensure that the test methodologies are appropriately selected and validated/verified for clinical use.
• Ensure that a sufficient number of laboratory personnel are trained and competent to produce accurate and reliable results.
• Ensure that the laboratory is enrolled in an appropriate proficiency testing program for the testing performed, and that proficiency testing results are reviewed and acted upon according to regulatory requirements.
• Ensure that the quality control and quality assessment programs are established and are maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur.
• Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system.
• Ensure that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory's established performance characteristics are identified, and that patient test results are reported only when the system is functioning properly.
• Ensure that reports of test results include pertinent information required for interpretation.
• Ensure that consultation is available to the laboratory's clients on matters relating to the quality of the test results reported and their interpretation concerning specific patient conditions.
• Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process.
• Specify, in writing, the responsibilities and duties of each individual authorized to perform clinical testing, and whether supervision is required.

Required qualifications

• MD degree or equivalent with specialized training, and experience in molecular genetics, molecular pathology, or related field.
• Qualification as a healthcare service director approved by the licensing authority (Valvira).
• Minimum of 5+ years of clinical experience with various techniques; high throughput DNA sequencing in a commercial, academic, or government laboratory desirable.
• Appropriate board certification preferred.
• Experience with quality assurance and quality Control in clinical diagnostics.
• Must be detail-oriented, and highly organized, with excellent verbal and written communication skills.

Working Conditions: (describe office, loading dock, lab environment, include shifts and any travel)

• Clinical laboratory environment; exposure to blood-borne pathogens, and hazardous chemicals; must wear personal protective equipment including a lab coat, gloves, and completely closed footwear.
• Participation in audio/conference calls with laboratory staff required.
• Travel to the site is required.

Physical Requirements:

• While performing the duties of this job, the employee is regularly required to sit, use a keyboard, type, and occasionally stand and move to other parts of the lab.