Lab Director – Valencia, California

Duties and Responsibilities :
• Ensure that laboratory testing systems provide quality laboratory services for preanalytic, analytic, and postanalytic phases of testing.

• Ensure that the 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.

• Ensure that test methodologies are appropriately selected and validated / verified for clinical use.

• Ensure that laboratory personnel are trained and competent to produce accurate and reliable results.

• Ensure that the laboratory is enrolled in an HHS-approved proficiency testing program for the testing performed, reviewed, and acted upon according to regulatory requirements.

• Ensure that the 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.

• 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 a general supervisor provides on-site supervision of high complexity test performance by testing personnel qualified under § 493.1489(b)(4).

• Employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to ensure accuracy in clinical testing.

• Ensure that prior to testing patients’ specimens, all personnel have the appropriate education and experience, receive the appropriate training.

• Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency, and whenever necessary, identify needs for remedial training or continuing education to improve skills.

• 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 consultant, each supervisor, and each individual authorized to perform clinical testing, and whether supervision is required.

In addition :
• Ensure that the laboratory meets or exceeds CLIA and local regulatory requirements.

• Maintain good communication with leadership, team members and customers.

• Ensure safety, security, and the environment in all aspect of the daily activities, and any potential safety hazards are addressed and corrected immediately.

• Understand ergonomic relationship between people, equipment and working environment.

• Other duties as assigned.

Required Qualifications :
• MD with current CA medical license.

• Hold a current CA Laboratory Director’s License.

• 5 years of clinical experience in molecular genetics, molecular pathology, virology or related field.

• Must be detail oriented, organized, with excellent verbal and written communication skills.

• Experience with LIMS and laboratory automation highly desired.

• Computer literate with advanced levels of experience using the following: Excel, Word, PowerPoint to generate business reports and presentations.

• Able to work effectively and able to deliver on tight datelines.

Working Conditions :
• Clinical and research lab environment; exposure to blood borne pathogens; must wear personal protective equipment including lab coat, gloves and completely closed footwear.

• Employee may be requested to work shifts other than daylight depending on the needs of the laboratory.

• Weekend rotation may be required.

• Travel is not required.

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

• Must be able to physically stand for several hours with good mobility.

• Reach above/below the shoulder, bend at the knees and waist.

N othing in this job description restricts management’s right to assign or reassign duties and responsibilities of this job at any time.