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.
Supervisory Responsibilities/Direct Reports:
N/A
Difficulty of Work:
Incumbent is engaged in scientific analyses that demand accuracy and
demonstrated proficiency in applying laboratory analytical skills to select
pertinent guidelines and formulated plans for problem solving. Projects involve
many complex variables of great intricacy and the microbiologist is often called
upon to analyze and identify unusual specimens/samples. Work requires
considerable use of analytical judgement and technical knowledge in order to
draw accurate, logical conclusions. Incumbent will also be required to develop
and research new testing procedures.
Responsibility:
Incumbent works independently as an expert in the Biothreat laboratory.
Technical and/or detailed instruction is provided only upon request when a
procedural change and/or special project necessitates it. Incumbent maintains
established safety practices when working with materials that have a chemical
hazard or biohazard potential. Reports are reviewed for general technical
accuracy; however, tasks are performed independently. Errors in work could
adversely affect the health, safety and well being of the incumbent or
coworkers.
Personal Work Relationships:
Incumbent works with supervisor and with other Department of Health staff such
as Laboratory Safety Officer and/or external entities (e.g. local health
departments, etc.) to devise and implement work procedures and information
dissemination. Individual will have contact with employees and the public as a
laboratory expert and in the explanation of laboratory procedures and
recommendations when appropriate.
Physical Effort:
The incumbent will be performing tests on potentially dangerous samples (e.g.
anthrax). Because of this, safety standards are of primary importance. This
position will be required to use all appropriate personal protective equipment
in the designated laboratory area.
Working Conditions:
The equipment can be cumbersome and awkward; the laboratory space can experience
a dramatic increase in temperature. The incumbent will be required to work in
these conditions and maintain a clear thought process during the testing.A
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