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.
• 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.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
• 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.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
• Bachelors degree in biology or chemistry and 3 years’ 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 GLP and/or CLIA guidelines preferred.
• DNA and RNA Sequencing, Genotyping, Gene Expression, or DNA/RNA Isolations experience.
Quintiles Transnational - 16 months ago
Quintiles Transnational has plenty to CRO about. One of the world's top contract research organizations (CROs), it...