Lab Associate 2 -Genomics

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 Overview
Responsible for performing routine analysis and laboratory testing procedures within the Molecular, Genomics, Clinical Testing group to obtain data for use in drug development and clinical trials research.  Perform IUO, CDx, LDT, or IVD genomics assays in accordance with ICH E6 Guideline for Good Clinical Practice.  Performs additional functions in support of Clinical Testing including laboratory maintenance, inventory management, and data recording and communication.  

Essential Functions
• Responsible for performing and documenting analytical procedures in accordance with SOPs and regulatory guidelines.
• Performs routine data analysis to determine if an analytical procedure is proceeding according to expectations and that the results are within acceptable tolerances.
• Identifies and documents potential performance errors or otherwise unusual results and escalates to senior lab personnel.
• Prepares data analysis results for upload to LIMS system under the guiadance of senior level staff.
• Assists in quality investigations, deviations, and resolution.
• Prepares buffers and solutions for analysis, as required.
• Assists in the review and update of laboratory procedures and techniques.
• Guides entry level staff on routine procedures and supports on-boarding of new staff.
• Performs and document calibration and maintenance of laboratory equipment as assigned.
• Performs and documents hands on training for other lab personnel in areas of proven competency as assigned.
• Assists in the review and development of laboratory procedures and techniques.
• Assists in the implementation of procedural changes as assigned.
• Notifies inventory staff of supply shortages.
• May represent lab team on cross functional projects.
• Responsible for clear, accurate, and timely communications with cross functional stakeholders.
• Participates in continuing education through self-study, attending training sessions and lectures and meetings.
• Supports safety, quality, and 6S requirements and initiatives.
• Complies with company's procedures and applicable regulatory requirements.

Qualifications
• Bachelors Degree or educational equivalent in medical technology
• Preferred 2 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.  
• Requires basic knowledge of assigned technical area, systems and procedures obtained through prior work experience.
• Demonstrates understanding of functional area and responsibilities.
• Working knowledge of any applicable regulatory standards within area of responsibility, such as Good Laboratory Practices (GLP).
• Proficiency with relevant 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 routine and some non-routine laboratory calculations regarding batches and specimens including averages, means, standard deviations, and various quality control metrics.
• Good computer skills using Microsoft Outlook, Word and Excel.
• Capable of handling multiple tasks simultaneously.
• Strong attention to detail and accuracy.
• Ability to effectively collaborate with internal stakeholders.
•  Applicable certificaand/or other regulatory bodies by country, state, and/or other regulatory bodies  R

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.