Genomic Laboratory Specialist

  • Company: IQVIA
  • Location: Durham, North Carolina
  • Posted: November 16, 2017
  • Reference ID: 1719536
Job Description
Launched in 2015, Q2 Solutions is a leading global clinical trials laboratory services organization. We help biopharmaceutical, medical device and diagnostics customers improve human health through innovation that transforms science and data into actionable medical insights. Q2 Solutions is a quality driven, responsive partner with strong global experience and deep scientific and medical expertise. The Q2 Solutions joint venture was formed by Quintiles and Quest Diagnostics, combining the best of each parent organizations clinical trials laboratory services capabilities.


Act as a technical specialist for genomic laboratory operations including identifying and driving continuous process improvement, supplyingexpertise on matrix-based project teams for business objectives, and providing flex staffing for molecular laboratory operations.

  • Adhere to all EA policies, procedures and employee handbook contents.
  • Serve as a laboratory expert on individual or cross functional team projects to support business initiatives, including but not limited to the following:
    • Assay development, automation, operationalization, and analytical enhancement.
    • Evaluation, on-boarding, and implementation of new technology and instrumentation.
    • Laboratory logistics and workflows.
    • Technology and assay transfer
  • Identify, lead, and deliver continuous process improvements for laboratory operations, including but not limited to the following responsibilities:
    • Assist partners in formalizing and addressing issues and ideas.
    • Review or establish laboratory metrics to identify, justify, or define impact of process improvement initiatives.
    • Generate, test, and pilot creative solutions.
    • Independently find and evaluate vendor platforms.
    • Perform project management, coordinating with collaborators, presenting to stakeholders, and ensuring goals and timelines are met.
    • Document project deliverables including formal validations and technical reports.
    • Complete organized change control and change management.
    • Present findings to a wide variety of audiences.
    • Increase data quality, lower costs, and reduce turnaround times.
  • Act as flex support in any area of daily laboratory operations, and meet expectations of thelaboratory associate job responsibilities in that area.
  • Perform and document all specimen test procedures with accuracy, consistency and timeliness in accordance with current standard operating procedures (SOPs) and regulatory and corporate guidelines.
  • Exercise good judgment in assessing whether test procedure is proceeding according to expectations and acceptable results, and to escalate to supervisors immediately should anomalies or potential QC failures arise.
  • Perform and document training for other associates in areas of proven competency as assigned.
  • Demonstrate advanced domain knowledge to provide input on technical inquiries and provide leadership in troubleshooting projects. Including application of root cause analysis and advanced problem solving techniques.
  • Produce technical documentation for laboratory assays and associated pipelines to support various business groups (e.g. Laboratory Ops, Quality Systems, Sales, IT, and Finance).
  • Participate in continuing education through self-study, attending training sessions and off-site lectures and meetings.
  • Perform other activities as directed.

Job Requirements

  • Working knowledge of Good Laboratory Practices, Clinical Laboratory Improvement Amendments (CLIA) and other governing regulatory requirements.
  • Excellent oral and written communication skills.
  • Strong organizational skills, and close attention to detail are essential.
  • Capable of handling multiple tasks simultaneously and independently.
  • Demonstrated "everyday leadership" skills.
  • Expertise with pipetting and general molecular biology laboratory techniques. RNA/DNA isolation, NGS, or genomic assay experience preferred.
  • Aptitude with instrumentation in a high-throughput laboratory preferred.
  • Proficiency with experimental design, and laboratory calculations and statistics, including but not limited to mean, standard deviation, and various quality control metrics.
  • Experience with LIMS and electronic laboratory process documentation preferred.
  • Familiarity with Lean, Six Sigma, or continuous process improvement principles preferred.
  • Proficient user of standard office productivity software such as Microsoft Word, Excel and PowerPoint

Bachelor's degree with 4 years experience manipulating RNA and/or DNA in a clinical, research, academic or commercial/production environment; or equivalent combination of specialized experience and training in biology or chemistry laboratory environment.

  • Extensive use of keyboard requiring repetitive motion of fingers.
  • Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
  • Regular sitting for extended periods of time.
  • May require occasional travel.

EEO Minorities/Females/Protected Veterans/Disabled

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