Laboratory Site Manager

Company Description

At Eurofins Diatherix, a Eurofins company, you will participate in exciting new developments at the cutting-edge of molecular diagnostic science and technology. Our teams of dedicated professionals work together in an entrepreneurial atmosphere, providing a broad range of innovative tools and services to the clinical diagnostics and life science research markets.

Job Description

The Laboratory Site Manager is responsible for specimen labeling, processing, test performance and storage, lab maintenance, supply stocking, logging temperature and lot numbers, aliquoting reagents, and following standard lab procedures, safety guidelines, and HIPAA polices. The position is also responsible for processing samples with molecular technologies other than TEM-PCR, such as qPCR. On days assigned as lead, also responsible for reviewing patient testing data and QC results, reporting test results, overall direction of patient testing, and communication of testing to Client Services, clients, sales, and the next lead. Responsible for training and competency assessment of testing personnel. Responsible for supervision of the clinical laboratory operation and the personnel performing testing and reporting of test results. Responsible for the clinical lab training and competency program, maintenance of laboratory inventory, and assuring test performance remains within lab specifications.

Must be accessible to testing personnel at all times testing is performed when assigned as Technical Supervisor to provide on-site, telephone or electronic consultation to resolve technical problems in accordance with policies and procedures established by the Laboratory Director.

Specific Job Functions:

Specimen Labeling and Assistance Duties (minimally perform)

• Check specimens for proper identification and test orders. Label for testing and with any error codes that apply to specimen preparation and transport.
• Properly seal and store specimens at the appropriate temperature after testing.
• Double check all packaging, boxes, biohazard bags, and sorting areas for missing specimens or requisitions.
• Clean and maintain the specimen labeling area.
• Clean and maintain all laboratory areas according to the Clinical Lab Cleaning Schedule and properly document and date cleaning or maintenance performed.
• Understand and follow reagent labeling and handling procedures during preparation of wash plates for extraction procedures.
• Prepare wash plates for extraction procedures according to standard procedures.

Technical Duties

• Follow the laboratory's procedures for specimen handling and processing, test analyses, and maintaining records of patient test results.
• Maintain records that demonstrate that proficiency testing samples are tested in the same manner as patient specimens.
• Document instrument and procedural calibrations and maintenance performed.
• Follow the laboratory’s established policies and procedures whenever test systems are not within the laboratory’s established acceptable levels of performance.
• Document all corrective actions taken when test systems deviate from the laboratory’s established performance specifications.
• Understand and follow procedures for specimen, batch, and plate labeling and identification so that specimen traceability is maintained through the entire high-throughput, teamwork testing process.
• Understand and follow reagent labeling and handling procedures.
• Performance of TEM-PCR lab duties is expected to be accurate and efficient after initial 6 month competency assessment and maintained at an acceptable level thereafter.
• Clean and decontaminate laboratory testing areas according to procedure after each day’s testing is complete in the area.
• Stock laboratory with supplies.

Advanced Technical Duties

• Setup and perform testing of samples for troubleshooting, clinical, and stability studies.
• Setup and assist with testing of samples for validation and verification studies of laboratory tests.
• Properly document records of studies performed, assuring traceability of dates, samples, reagent lots, equipment IDs, and other pertinent records.
• Performance of qPCR and other molecular lab technologies is expected to be accurate and efficient after initial 6 month competency assessment of each specific task and maintained at acceptable levels thereafter. 
• Proper handling of instrument blocks for qPCR equipment when switching between 96-well and OpenArray blocks on a QuantStudio 12K or other similar equipment as used in the laboratory.

QC Duties

• Assure reagents are QC tested before use with patient testing or concurrently with their first use.
• Properly document a