Laboratory Site Manager

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.

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 and file QC records and data.
• Analyze and review QC data, in consultation with lab manager when needed.
• Periodically review for reagents approaching their expiration date and handle accordingly.
• Oversight of QC testing, documentation, labeling, and storage of incoming reagents to be used for clinical testing.

Lead Duties

• Responsible for clinical testing to the end on the day assigned, assuring all items are complete on the Clinical Lead Checklist.
• Handle problems, troubleshooting, and judgment calls when situations arrive that are not addressed in any procedure, which includes consulting with a Technical Supervisor or the Laboratory Director when needed.
• Review communication channels frequently to assure all timely needs are handled and all updates are communicated properly.
• Document processing errors, nonconformances, or deviations from standard procedure that may occur on day’s assigned as lead.
• Coordinate any delayed testing and delay notifications according to policy.
• Assure all repeat specimens are in testing, the sync between accessioning and batching each day is correct, and client error resolutions are in testing. Assure no specimen is delayed testing due to an oversight.
• Verify client errors and log them in the Laboratory Information System.
• Direct the overall flow of testing, keeping in mind quality, efficiency, and TAT, on days assigned as lead.
• Enter, review, verify, and release patient results in the Laboratory Information System.
• Assure that all testing is complete, all issues are resolved, and any late testing is covered if the need arises before leaving for the day.

Management Duties

• Follow up with direct reports on nonconformances or errors and assure issue is corrected or additional training is provided.
• Perform performance evaluations of direct reports.
• Perform and document training and competency assessment for lab employees.
• Handle disciplinary issues involving employee conflict or continued offenses.
• Provide day-to-day supervision of high complexity test performance by testing personnel.
• Responsible for the technical and functional oversight of the laboratory, in conjunction with the Clinical Lab Manager.
• Monitor test analyses and specimen examinations to ensure that acceptable levels of analytic performance are maintained.
• Maintain a sufficient inventory of supplies for patient testing.
• Ensure testing records are complete and filed away appropriately.
• Prepare weekly work schedules, including schedules for training and competency assessments.
• Prepare weekly orders of reagents and supplies and additional orders as needed.
• Prepare quarterly forecasts and orders for vendors with quarterly order agreements.
• Review quality and control monitors and initiate action as needed.
• Laboratory Information System management.

Lab Responsibilities

• Verification of the test procedures performed and establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system.
• Participation in a proficiency testing program commensurate with the services offered.
• Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis, and reporting of test results.
• Resolving technical problems and ensuring that remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications.
• Ensuring that patient test results are not reported until all corrective actions have been taken and the test system is functioning properly.
• Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed.
• Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately, and proficiently.
• Assessment of test performance through testing previously analyzed specimens, internal blind testing samples, or external proficiency testing samples.
• Assessment of problem solving skills
• Evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. Thereafter, evaluations must be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation.

• Bachelor of Science in Medical Service Laboratory or Life Science
• Qualify as a Technical Supervisor as defined by CLIA and State Regulations
• Must possess proficiency with basic computer programs.
• Must be able to multitask and keep up in a fast-paced environment.
• Must work well on your own with minimal supervision.
• Must demonstrate key problem solving skills: active listening, analysis, research, creativity, communication, dependability, decision making, and team building.

Third shift 1am - 12pm

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.