Medical Technologist - Genomics

at  Q Solutions

Job Overview
Perform a wide variety of routine and complex testing procedures to obtain data from client specimens. Provide documentation and review of work performed in a timely manner.

Essential Responsibilities:

• End to end delivery of analytical and pre-analytical lab services to support clinical trials. Includes kit receipt, specimen management, specimen preparation and lab analysis across a broad spectrum of methods and technologies.
• Responsible for completing and preparing documentation and laboratory testing in accordance with applicable regulatory and corporate guidelines.
• Perform a variety of testing procedures with accuracy, consistency and timeliness in accordance with current standard operating procedures (SOPs) and perform work in accordance with ICH E6 Guideline for Good Clinical Practice.
• Exercise good judgment in assessing whether test procedure is proceeding according to expectations and that the results are within acceptable tolerances.
• Identify abnormal progress of test procedure, potential QC failures, or otherwise unusual results and escalate to senior lab personnel immediately.
• Perform and document hands on training for other Laboratory Technicians in areas of proven competency as assigned.
• Perform and document calibration and maintenance of laboratory equipment and reagent qualification/QC as assigned.
• Document corrective and preventative actions taken using good documentation practices.
• Assist management in establishing new methodologies and completion of development packages
• Assist management in process improvements to increase data quality, lower costs, or reduce turnaround times. Includes, updating SOPs/PTR’s for laboratory testing, safety procedures and assisting with troubleshooting.
• Identify appropriate vendors and order laboratory supplies as directed by management in order to maintain consistent workflow.
• May represent laboratory team on cross functional projects.
• Participate in continuing education through self-study, attending training sessions and off-site lectures and meetings.

Qualifications:

• Bachelor’s Degree in biology or chemistry required
• 3 years experience in a clinical laboratory operating under GLP and/or CLIA guidelines required OR
• 1 year experience in a clinical, research, academic or commercial/production laboratory environment required OR
• Equivalent combination of education, training and experience required
• Experience in a clinical laboratory operating under GLP and/or CLIA guidelines Req
• DNA and RNA Next Generation Sequencing, Genotyping, Gene Expression, or DNA/RNA Isolations experience in a clinical, research, academic or commercial/production laboratory environment
• Working knowledge of Good Laboratory Practices (GLP) and other regulatory agency standards within the area of responsibility such as CLIA requirements
• Proficiency with pipetting and molecular biology laboratory techniques
• Knowledge of laboratory safety and infection control procedures and practices including standard precautions and hazardous chemical handling
• Experience working with automation or specialized laboratory equipment.
• Proficiency with more complex laboratory calculations regarding batches and specimens including averages, means, standard deviations, and various quality control metrics.
• Experience using Microsoft Outlook, Word and Excel.
• Capable of handling multiple tasks simultaneously.
• Strong attention to detail and accuracy
• Ability to establish and maintain effective working relationships with coworkers, managers and clients

Q² Solutions, IQVIA’s laboratory business, creates connected intelligence by combining our expertise, technology and analytics - this fuels unparalleled research & development solutions. We uphold a deep commitment to patients, sites, customers, and each other. https://www.q2labsolutions.com/career

• End to end delivery of analytical and pre-analytical lab services to support clinical trials. Includes kit receipt, specimen management, specimen preparation and lab analysis across a broad spectrum of methods and technologies.
• Responsible for completing and preparing documentation and laboratory testing in accordance with applicable regulatory and corporate guidelines.
• Perform a variety of testing procedures with accuracy, consistency and timeliness in accordance with current standard operating procedures (SOPs) and perform work in accordance with ICH E6 Guideline for Good Clinical Practice.
• Exercise good judgment in assessing whether test procedure is proceeding according to expectations and that the results are within acceptable tolerances.
• Identify abnormal progress of test procedure, potential QC failures, or otherwise unusual results and escalate to senior lab personnel immediately.
• Perform and document hands on training for other Laboratory Technicians in areas of proven competency as assigned.
• Perform and document calibration and maintenance of laboratory equipment and reagent qualification/QC as assigned.
• Document corrective and preventative actions taken using good documentation practices.
• Assist management in establishing new methodologies and completion of development packages
• Assist management in process improvements to increase data quality, lower costs, or reduce turnaround times. Includes, updating SOPs/PTR’s for laboratory testing, safety procedures and assisting with troubleshooting.
• Identify appropriate vendors and order laboratory supplies as directed by management in order to maintain consistent workflow.
• May represent laboratory team on cross functional projects.
• Participate in continuing education through self-study, attending training sessions and off-site lectures and meetings