Clinical Laboratory Manager

Provide daily technical and operational supervision of a high throughput clinical laboratory including oversight of laboratory technologists, technical trouble-shooting of validation and testing processes, review of results, develop and write operational procedures, monitor laboratory key performance indicators, quality metrics and the QC program, report quality events to the laboratory director and to quality management, and provide regulatory, due diligence and internal auditing support.

Duties and Responsibilities:

• Manage the daily operations of assigned laboratory personnel to ensure that specimens are properly shipped and received, tests are performed accurately and efficiently, and results are reported in a timely manner.
• Perform pre-analytical, analytical and post analytical test process and evaluate results produced relative to the diagnostic assessment.
• Evaluate data for accuracy and verify any questionable finding with proper documentation, thorough investigation, and appropriate follow-through: ensure that acceptable levels of analytic performance (quality controls) are maintained through the testing process and that patient results are not reported until all corrective actions have been taken and test system is functioning properly.
• Assist with designing processes and procedures to ensure efficient turn-around time and accuracy of results.
• Prepare and manage laboratory budget.
• Coach and mentor staff on technical expertise, identify training needs, assure that technical staff receive regular in-service training and education appropriate for the type of tasks performed and evaluate employee competency.
• Engage in continuous process and service improvement. Make and implement recommendations to improve operational efficiency, and accuracy of results.
• Ensure safety and security in the work environment related to all daily activities, and immediately address any potential safety hazards.
• Understand ergonomic relationship between people, equipment and working environment.
• Ensure all work is in accordance with state and Federal regulations, organizational policy, and accreditation/compliance requirements.
• Assist in maintaining regulatory agency standards and regulations.
• Performing bench work and other duties as required including shift work.
• Maintain good communication with leadership, team members and customers.
• Other duties as assigned.

Required Qualifications:

• Must meet qualifications established by CLIA for Technical Supervisor: CFR Subpart M §493.1449.
• MD or PhD, MS, BS Degree in chemical, physical, biological or clinical laboratory science or medical technology.

AND

• Experience in both Microbiology and Virology dependent on level of education.
• M.D. and at least one year of lab training or experience in high complexity testing in microbiology with a minimum of 6 months experience in virology unless board certified in clinical and anatomical pathology.

OR

• PhD and at least one year of laboratory training or experience in high complexity testing in microbiology with a minimum of 6 months experience in virology.

OR

• Masters and at least two years of laboratory training or experience in high complexity testing in microbiology with a minimum of 6 months experience in virology.

OR

• Bachelors and at least 4 years of laboratory training or experience in high complexity testing in microbiology with a minimum of 6 months experience in virology.
• Minimum one year clinical molecular biology experience.
• Previous Supervisory/Management experience in a clinical laboratory setting.
• Knowledgeable of Quality Assurance and Quality Control applications in clinical diagnostics.
• Must be detail-oriented, well-organized, with excellent verbal and written communication skills.
• Ability to troubleshoot technical applications and work independently under pressure of deadlines and a fast paced, high throughput team environment.
• Practical knowledge of routine laboratory equipment and procedures.
• Experience with LIMS and laboratory automation highly desired.
• Able to work effectively and able to deliver on tight datelines.

Recommended Qualifications:

• Laboratory Personnel License Certification (e.g. CLS, ACSP, ASCPi, AAB, AMT, MTE), highly preferred.
• Extensive experience of clinical molecular experience, preferred

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 have manual dexterity to use lab equipment
• Reach above/below the shoulder, bend at the knees and waist
• Able to lift boxes up to 25 pounds

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities of this job at any time.