NGS Specialist - American Technology Consulting

This position is part of the Indiana Department of Health Laboratory, AdvancedMolecular Detection DivisionPurpose of Position/Summary:Incumbent is responsible for coordinating and performing the full range ofmolecular biological examinations and analyses, recording, interpreting, andresult reporting of tests on specimens which may include human body fluids,tissues (human and animal), isolates from clinical specimens, and environmentalsamples to the submitting physician, clinic, hospital, or public health agency.Incumbent is also responsible for the development, validation, andimplementation of new molecular tests, preparation of validation documents andSOPs, and troubleshooting of the existing molecular tests. Special emphasis forthis position will be around genomic sequencing, maintenance of instrumentationfor sequencing, and troubleshooting sequencing assays.Essential Duties/Responsibilities:Incumbent will have in-depth knowledge and ability in the areas of molecularbiology and is able to perform laboratory associated assays or the ability tolearn these techniques upon successful completion of proficiency testing.Representative duties include:• Extraction of nucleic acids from specimens, isolates, and samples via avariety of manual and automated methods;•Utilize molecular techniques such as, but not limited to, PCR, MALDI-TOF, andNGS;•Participate in the evaluation, development, validation, and implementation ofnew 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 complexitytesting; strictly following the laboratory's procedures for specimen handlingand processing, test analyses, reporting, and maintaining records of testresults;• Maintain laboratory record system of submitted samples and specimens and theirpossible referral;• Evaluate, interpret, validate laboratory results, and report findings;• Conduct quality control checks on laboratory methods, materials, andequipment;• Document all quality control activities, instrument calibrations, andmaintenance performed;• Participate in evaluation of new products used in clinical/referencelaboratory work;• Perform all related work as required;•Testing personnel responsibilities (42 CFR 493.1495 Standard):The testing personnel are responsible for specimen processing, test performanceand for reporting test results.(a) Each individual performs only those high complexity tests that areauthorized by the laboratory director and require a degree of skill commensuratewith the individual’s education, training or experience, and technicalabilities.(b) Each individual performing high complexity testing must—(1) Follow the laboratory’s procedures for specimen handling andprocessing, test analyses, reporting and maintaining records of patienttest results;(2) Maintain records that demonstrate that proficiency testing samples aretested in the same manner as patient specimens;(3) Adhere to the laboratory’s quality control policies, document all qualitycontrol activities, instrument and procedural calibrations andmaintenance performed;(4) Follow the laboratory’s established policies and procedures whenevertest systems are not within the laboratory’s established acceptable levelsof performance;(5) Be capable of identifying problems that may adversely affect testperformance or reporting of test results and either must correct theproblems or immediately notify the general supervisor, technicalsupervisor, clinical consultant, or director;(6) Document all corrective actions taken when test systems deviate fromthe 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 wereperforminghigh complexity testing on or before January 19, 1993, the requirements ofparagraph (b)(7) of this section are not effective, provided that all highcomplexitytesting performed by the individual in the absence of a general supervisor isreviewed within 24 hours by a general supervisor qualified under § 493.1461Job Requirements:• Extensive knowledge of the principles, theories and practices of molecularbiology, and related sub- specialties;• Experience with Next Generation Sequencing platforms, technologies, andprocedures.• Specialized knowledge of current scientific methods and testing procedures andthe ability to apply them when seeking solutions to public health laboratoryproblems;• Specialized knowledge of and ability to use a full range of standard technicalequipment, 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 concerningthe program area (i.e. CLIA);• Ability to meet requirements for personnel certification as a technologistpursuant to the Clinical Laboratory Improvement Act (CLIA)• Ability to effectively communicate technical information both verbally and inwriting and maintain productive working relationships;• Ability to satisfactorily participate in proficiency testing programs andrecognize QA problems;• Ability to compile, analyze, evaluate, and prepare laboratory reports.Supervisory Responsibilities/Direct Reports:N/ADifficulty of Work:Incumbent is engaged in scientific analyses that demand accuracy anddemonstrated proficiency in applying laboratory analytical skills to selectpertinent guidelines and formulated plans for problem solving. Projects involvemany complex variables of great intricacy and the microbiologist is often calledupon to analyze and identify unusual specimens/samples. Work requiresconsiderable use of analytical judgement and technical knowledge in order todraw accurate, logical conclusions. Incumbent will also be required to developand 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 aprocedural change and/or special project necessitates it. Incumbent maintainsestablished safety practices when working with materials that have a chemicalhazard or biohazard potential. Reports are reviewed for general technicalaccuracy; however, tasks are performed independently. Errors in work couldadversely affect the health, safety and well being of the incumbent orcoworkers.Personal Work Relationships:Incumbent works with supervisor and with other Department of Health staff suchas Laboratory Safety Officer and/or external entities (e.g. local healthdepartments, etc.) to devise and implement work procedures and informationdissemination. Individual will have contact with employees and the public as alaboratory expert and in the explanation of laboratory procedures andrecommendations 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. Thisposition will be required to use all appropriate personal protective equipmentin the designated laboratory area.Working Conditions:The equipment can be cumbersome and awkward; the laboratory space can experiencea dramatic increase in temperature. The incumbent will be required to work inthese conditions and maintain a clear thought process during the testing.