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.
Perform a wide variety of routine and complex genomic testing procedures to obtain data from client specimens. Provide documentation and review of work performed in a timely manner.
- Adhere to all EA Genomics policies and procedures.
- 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 the review and development of laboratory procedures and techniques, including transitioning new assays from R&D to production.
- Assist in process improvements to increase data quality, lower costs, or reduce turnaround times. Includes, updating SOPs/PTR's, assisting with troubleshooting.
- May represent laboratory team on cross functional projects.
- Participate in continuing education through self-study, attending training sessions and off-site lectures and meetings.
All responsibilities are essential job functions unless noted as nonessential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Working knowledge of Good Clinical Laboratory Practices (GCLP) and other regulatory agency standards within the area of responsibility such as CLIA requirements
- Proficiency with pipetting and molecular biology laboratory techniques. RNA/DNA isolation, NGS, or genomic assay experience preferred.
- 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 more complex laboratory calculations regarding batches and specimens including averages, means, standard deviations, and various quality control metrics.
- Experience using Microsoft 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
- Excellent oral and written communication. Strong organizational skills.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Bachelor's degree in biology or chemistry and 2+ years of experience manipulating RNA and/or DNA in a clinical, research, academic or commercial/production laboratory environment; or equivalent combination of education, training and experience.
- Experience in a clinical laboratory operating under GCLP and/or CLIA guidelines preferred.
- DNA and RNA Sequencing, Next Generation Sequencing, Genotyping, Gene Expression, or DNA/RNA isolations experience is preferred. Candidates with other complex and sensitive laboratory testing experience (e.g. cell culture, ELISA) are also encouraged to apply.
- Work is performed in a laboratory environment, full manual dexterity and visual acuity required.
- Regular standing or sitting for extended periods of time
- May be exposed to potential physical harm from hazardous chemicals, infectious diseases, blood-borne pathogens, toxic materials, toxic gases, electrical hazards, dangerous tools and equipment.
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
EEO Minorities/Females/Protected Veterans/Disabled
Job ID: R1066310