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Clinical Laboratory Director

  • LocationHummelstown, PA 17036 - United States
  • Work TypeFull time
  • Positions1 Position
  • Published At:10 days ago
  • Job no: 41897
  • Category: R&D

Job Description

A leading company in the biotechnology industry is currently seeking a Clinical Laboratory Director to join their team. The role will be challenging but also highly rewarding and this leader will be a key voice in the company. For the right executive, this is a fantastic opportunity with great growth prospects. Key duties include:

1) Administer and supervise the personnel and operations of the laboratory

2) Ensure that the laboratory is enrolled in an HHS-approved proficiency testing program for the tests performed and the proficiency testing samples are tested as required by CLIA

3) Prepare corrective action plans when any proficiency testing is unacceptable or unsatisfactory

4) Maintain an effective working relationship with applicable accrediting and regulatory agencies, administrative officials, and the medical community

5) Designate a Quality Systems Manager who has the training, experience and authority to provide effective leadership for activities necessary to ensure communication, training, competency assessment and ongoing compliance monitoring with requirements under the laboratory’s quality management system

6) Define QA goals and process objectives for the quality system, approval of specifications and requirements established to achieve stated goals and objectives, review QA reports, and approve process improvement initiatives

7) Ensure an effective quality management program for the laboratory

8) Ensure that test systems developed and used for each test performed in the laboratory provide quality laboratory service for all aspects of test performance, which include pre-analytic, analytic, and post-analytic phases of testing

9) Ensure that the physical and environmental conditions of the laboratory are appropriate for the testing performed and provide a safe environment in which employees are protected from physical, chemical and biological hazards

10) Ensure that a qualified General Supervisor provides on-site supervision of all testing personnel

11) Supervise lab staff to ensure that tests are accurately performed and reported

12) Ensure that qualified personnel are employed including, where applicable that staff are not engaged in practices limited by license or beyond the scope of licensure

13) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results

14) Provide an approved procedure manual to all personnel responsible for any aspect of the testing process

15) Write the responsibilities and duties of all laboratory personnel, including technical staff, supervisors, laboratory mangers, administrators, assistant directors, consultants and Laboratory Director

16) Participate in laboratory operational meeting that discuss the laboratory’s strategic planning and process development’s research and validation for assessing the clinical needs, assessing the implementation of changes from process changes and evaluating solutions to problems

17) Ensure the reporting of results to cancer registries as required by licensing and laws

18) Access PHI as appropriate to perform designated duties

19) Delegate, as appropriate, responsibilities to other laboratory personnel utilizing appropriate SOP form

20) Ensure that the test methodologies selected have the capability of providing the quality of results required for patient care

21) Verify that procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method and that laboratory personnel perform the test methods as required for accurate and reliable results

22) Ensure that quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur

23) Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system

24) Ensure that all 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 test is functioning properly

25) Ensure that the reports of test results include pertinent information required for interpretation

26) Ensure that consultation is available to the laboratory's customers on matters relating to the quality of the test results reported and their interpretation concerning specific patient conditions

27) Ensure provisions of consultation regarding the ordering of the appropriate tests and medical significance of the laboratory data

28) Ensure that policies and procedures are established for monitoring individuals who conduct pre-analytical, analytical, and post-analytical phases of testing to assure that they are competent and maintain their competency to process specimens

29) Perform test procedures and report test results promptly and proficiently, and whenever necessary to identify needs for remedial training or continuing education to improve skills

30) Determine and approve the circumstances and duties where access to confidential information is appropriate

Critical Requirements

1) A university degree is required. Although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field

2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)

3) Recent experience in the biotechnology industry is strongly preferred

4) Preference will be given to candidates with recent experience in research and development

If you are qualified and looking to work with a well-established company – one of the top names in the industry – you should not let this opportunity pass by. However, for this Clinical Laboratory

  • Published on 23 Jun 2022, 1:10 PM