Senior Lab Associate

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.  A joint venture of IQVIA (formerly QuintilesIMS) and Quest Diagnostics, Q2 Solutions combines the best of each parent organization’s clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.

Job Overview

Perform a wide variety complex testing procedures to obtain data from client specimens. Provide documentation and review of  work performed in a timely manner.  Provide technical insight for equipment/platform selection and technical transfer of assays for the Production Laboratory. Performs work in accordance with ICH E6 Guideline for Good Clinical Practice.

Essential Functions

• Complete and prepare documentation in compliance with regulatory and corporate guidelines.
• Perform and document all specimen test procedures with accuracy, consistency and timeliness in accordance with current standard operating procedures (SOPs) and regulatory guidelines.
• 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 calibration and maintenance of laboratory equipment and reagent qualification/QC as assigned.
• Perform and document hands on training for other Laboratory Associates in areas of proven competency as assigned.
• Assist in transitioning new assays/methods from R&D into the Production Laboratory
• Assist in process improvements to increase data quality, lower costs, or reduce turnaround times to include, updating SOPs/PTR’s, assisting with troubleshooting.
• May lead a laboratory or cross functional project and assist with implementation.
• May act as a technical resource for laboratory staff and support the team in the absence of the Supervisor.
• Participate in continuing education through self-study, attending training sessions and off-site lectures and meetings.

Qualifications

• Bachelor's Degree in biology or chemistry Req
• 3 years’ experience manipulating RNA and/or DNA in a clinical, research, academic or commercial/production laboratory environment Req Or
• Equivalent combination of education, training and experience Req
• Experience in a clinical laboratory operating under GLP and/or CLIA guidelines preferred Pref And
• DNA and RNA Sequencing, Genotyping, Gene Expression, or DNA/RNA Isolations experience Req And
• 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
• Strong technical knowledge of the s complex testing procedures and science supporting the analysis
• Proficiency with more complex laboratory calculations regarding batches and specimens including averages, means, standard deviations, and various quality control metrics.
• Ability to troubleshoot laboratory equipment and resolve process issues
• Experience using Microsft 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

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

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.