Purpose of Position/Summary:
Incumbent is responsible for coordinating and performing the full range of molecular biological examinations and analyses, recording, interpreting, and result reporting of tests on specimens which may include human body fluids, tissues (human and animal), isolates from clinical specimens, and environmental samples to the submitting physician, clinic, hospital, or public health agency. Incumbent is also responsible for the development, validation, and implementation of new molecular tests, preparation of validation documents and SOPs, and troubleshooting of the existing molecular tests. Special emphasis for this position will be around genomic sequencing, maintenance of instrumentation for sequencing, and troubleshooting sequencing assays.
Essential Duties/Responsibilities:
Incumbent will have in-depth knowledge and ability in the areas of molecular biology and is able to perform laboratory associated assays or the ability to learn these techniques upon successful completion of proficiency testing. Representative duties include:
Extraction of nucleic acids from specimens, isolates, and samples via a variety of manual and automated methods;
Utilize molecular techniques such as, but not limited to, PCR, MALDI-TOF, and NGS;
Participate in the evaluation, development, validation, and implementation of new testing methods used in clinical/reference laboratory work, as well as, preparation of validation documents and SOPs;
Provide technical oversight of the daily performance of high complexity testing; strictly following the laboratory's procedures for specimen handling and processing, test analyses, reporting, and maintaining records of test results;
Maintain laboratory record system of submitted samples and specimens and their possible referral;
Evaluate, interpret, validate laboratory results, and report findings;
Conduct quality control checks on laboratory methods, materials, and equipment;
Document all quality control activities, instrument calibrations, and maintenance performed;
Participate in evaluation of new products used in clinical/reference laboratory work;
Perform all related work as required;
Testing personnel responsibilities (42 CFR 493.1495 Standard):
The testing personnel are responsible for specimen processing, test performance and for reporting test results.
(a) Each individual performs only those high complexity tests that are authorized by the laboratory director and require a degree of skill commensurate with the individual's education, training or experience, and technical abilities.
(b) Each individual performing high complexity testing must-
(1) Follow the laboratory's procedures for specimen handling and
processing, test analyses, reporting and maintaining records of patient
test results;
(2) Maintain records that demonstrate that proficiency testing samples are
tested in the same manner as patient specimens;
(3) Adhere to the laboratory's quality control policies, document all quality
control activities, instrument and procedural calibrations and
maintenance performed;
(4) Follow the laboratory's established policies and procedures whenever
test systems are not within the laboratory's established acceptable levels
of performance;
(5) Be capable of identifying problems that may adversely affect test
performance or reporting of test results and either must correct the
problems or immediately notify the general supervisor, technical
supervisor, clinical consultant, or director;
(6) Document all corrective actions taken when test systems deviate from
the laboratory's established performance specifications; and
(7) Except as specified in paragraph (c) of this section, if qualified under
493.1489(b)(5), perform high complexity testing only under the onsite,
direct supervision of a general supervisor qualified under 493.1461.
(c) Exception. For individuals qualified under 493.1489(b)(5), who were performing
high complexity testing on or before January 19, 1993, the requirements of
paragraph (b)(7) of this section are not effective, provided that all high complexity
testing performed by the individual in the absence of a general supervisor is
reviewed within 24 hours by a general supervisor qualified under 493.1461
Job Requirements:
Extensive knowledge of the principles, theories and practices of molecular biology, and related sub- specialties;
Experience with Next Generation Sequencing platforms, technologies, and procedures.
Specialized knowledge of current scientific methods and testing procedures and the ability to apply them when seeking solutions to public health laboratory problems;
Specialized knowledge of and ability to use a full range of standard technical equipment, complex scientific apparatus, and automated techniques of analysis;
Extensive knowledge of laboratory safety practices and principles;
Aware of state and federal laws, rules, regulations, and policies concerning the program area (i.e. CLIA);
Ability to meet requirements for personnel certification as a technologist pursuant to the Clinical Laboratory Improvement Act (CLIA)
Ability to effectively communicate technical information both verbally and in writing and maintain productive working relationships;
Ability to satisfactorily participate in proficiency testing programs and recognize QA problems;
Ability to compile, analyze, evaluate, and prepare laboratory reports.