Associate Scientist, Validation Sample Prep

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 Summary

Works as part of a team also consisting of LCMS Analyst and Study Lead. Performs validation experiments pertaining to regulated bioanalysis in accordance with Q2 SOPs by following methods that have completed the method development/transfer process at Q2.  Will generate run documentation and data and will also be involved in method troubleshooting as necessary.  Prepares routine solutions and reagents. Assists in maintaining laboratory equipment, supports lab safety, and complies with Q2 Solutions procedures and Good Laboratory Practice (GLP) requirements, as applicable.

Responsibilities

• Working in a collaborative manner with LCMS Analyst, will perform validation activities to include
• Perform Wet Lab review of analytical methods being presented in Pre-Validation meetings
• Attend Pre-Validation Meetings; may sign as approver for Wet Labs
• Work with LCMS Analyst to prepare run instructions for each analytical run
• Prepare biological samples for quantitative and qualitative analysis. May assist with method development and troubleshooting.
• Update Analytical Method Summary promptly as necessary and submit for review and approval.
• Responsible for providing clear communication with the LCMS Analyst and Study Lead.
• Weigh reference compounds
• Prepare stock and working solutions/standards and QC samples.
• Aliquots control matrices.
• Make and record observations, perform calculations, and collect and prepare data for evaluation.
• Document and comply all project work according to Q2 Solutions and GLP processes and procedures, as applicable.
• Perform pipette maintenance and verification, and other laboratory maintenance as required.
• Assist in maintaining adequate supplies.
• Maintain housekeeping standards for work area.
• Work with automated instrumentation.
• Interface with Sample Management to request and return quality control samples.
• May use LIMS system to set-up and edit worklist and manage bioanalytical data.
• Clean glassware and sustain six sigma in wet laboratory areas
• Peer review wet laboratory preparations
• May be required to perform analytical activities in other pods as resourcing needs and priorities dictate

Minimum required education and experience

• Bachelor’s degree in Biology, Chemistry, or a related field; or equivalent combination of education, training and experience in a GLP analytical laboratory.

Required knowledge, skills and abilities

• Familiarity with Good Laboratory Practices (GLP)
• Basic knowledge of math and chemistry
• Basic mechanical skills
• Basic computer skills (e.g. word processing, spreadsheet, network navigation, etc.)
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Familiarity with a variety of pipettes
• 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.
• The ability and willingness to work with potentially hazardous chemicals and instrumentation.
• The ability to work with known infectious materials, radioactive materials, and analytes with a high occupational exposure band rating (safety measures provided)
• The ability and willingness to work with potentially hazardous chemicals and instrumentation.
• Moderate 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 and periodic standing.

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.