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Sr Scientist - Genomics Clinical Testing

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Primary Location: Durham, North Carolina, United States Full time R1234335

Job description

Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health. 

Job Summary

Responsible for serving as a technical specialist for laboratory operations within the Molecular Genomics Clinical Testing group. Act as lead on clinical studies including setup, training, tracking, troubleshooting, and coordination with internal and external study personnel on IUO, CDx, LDT, or IVD genomics assays. Identify and drive continuous process improvement initiatives within study and within the Clinical Testing infrastructure. Performs work in accordance with ICH E6 Guideline for Good Clinical Practice.

Responsibilities

  • Perform and document all specimen test procedures with accuracy, consistency and timeliness in accordance with current standard operating procedures (SOPs) and regulatory guidelines.
  • Complete and prepare documentation in compliance with regulatory and corporate guidelines.
  • Exercise good judgment in assessing whether test procedure is proceeding according to expectations and that results are within acceptable tolerances.
  • Perform and document hands on training for other Laboratory Associates in areas of proven competency as assigned.
  • Identify abnormal progress of test procedure, potential QC failures, or otherwise unusual results and escalate to Team Lead or Laboratory Management immediately.
  • Act as a back up in any area of daily laboratory operations, as needed, and meet expectations of the laboratory associate job responsibilities in that area.
  • Oversee the technology transfer of methods and SOPs from other groups within IQVIA such as Research and Development departments. This includes working with those departments to fill gaps that are identified to ensure the technology will be sustainable and scalable in laboratory operations.
  • 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 across all service areas in the business (i.e. Laboratory Ops, Quality Systems, Information Technology, and Finance).
  • Identify and lead continuous process improvement initiatives for laboratory operations, including but not limited to the following responsibilities:
  • Review of laboratory metrics to identify initiatives as well as establish additional metrics such as cost savings that are associated with process improvement initiatives.
  • Work with stakeholders on process improvement initiatives to present projects and ensure that goals are met.
  • Independently identify and evaluate vendor platforms to that may help meet goals of the initiatives.
  • Documentation of all project aspects including formal validations of laboratory methods.
  • Present findings to a wide variety of audiences internal and external to IQVIA.

Minimum Required Education and Experience

  • Bachelor's Degree Required
  • 4 years’ experience manipulating RNA and/or DNA in a clinical, research, academic or commercial/production environment Req Or Equivalent combination of specialized experience and training in biology or chemistry laboratory environment.
  • Preferred 4 years or more of hands-on experience/knowledge extracting RNA/DNA from biological specimens and performing gene expression or NGS (NextGen Sequencing) assays for clinical use.
  • Working knowledge of Good Laboratory Practices, Clinical Laboratory Improvement Amendments (CLIA) and any other governing regulatory requirements.
  • Expertise with pipetting and other general molecular biology laboratory techniques.
  • Proficiency with laboratory calculations regarding batches and specimens including but not limited to averages, means, standard deviations, and various quality control metrics.
  • 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

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.

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