Lead Technologist

Job Description
Position Summary:
The Technologist Lead 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.
Specific Job Functions:
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
Adhere to all processes put into place by the Quality Assurance and Safety Officer.
Consult with the QC Supervisor and/or the Quality Assurance and Safety Officer about all quality concerns in a timely fashion.
Ensure reagents are QC tested before use with patient testing or concurrently with their first use.
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, nonconformance, 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
Perform and document training and competency assessment for lab employees as assigned.
Maintain clear and accurate communication to Technical Supervisors and/or Administrative Operations Manager as needed.
Supervise daily performance of Molecular Technologist to ensure they are meeting our code of conduct and following all policy and procedures. Providing direction as needed.
Provide documentation on all performance issues not covered in the nonconformance log.
All Areas
Perform all work duties as assigned by shift on weekly work schedules, using any downtime for lab maintenance or other assigned duties.
Adhere to the laboratory's quality control policies and document all quality control activities.
Be capable of identifying problems that may adversely affect test performance or reporting of test results and correct the problem or immediately notify the day’s lead technologist or Technical Supervisor.
Participate in the laboratory’s quality assurance plan.
Participate in job specific training and annual competency assessment reviews.
Keep workstations clean according to the cleaning policy.
Wear personal protective equipment as required.
Observe all safety guidelines and report any unsafe conditions to a lab supervisor or manager.
Perform any additional duties as directed by Clinical Lab management.