Lab Operations Specialist

JOB PURPOSE & IMPACT<br>Provide laboratory operations support by assisting the technical staff with equipment, instrument, and/or reagent qualification and other lab support duties. Perform tasks accurately and on schedule. Know and follow all safety procedures and be able to respond appropriately.<br><br>ESSENTIAL DUTIES AND RESPONSIBILITIES<br>• Works in a GMP/GCP/GLP/CLIA regulated environment and is responsible for following all applicable regulations<br>• As assigned, assist in preventative maintenance, performance qualification and troubleshooting of instrumentation. Maintain inventory reports/logs according to established format/procedures.<br>• As assigned, assist in the performance of quality control procedures.<br>• As assigned, work in conjunction with external vendors and field service engineers to schedule instrument repair, relocation, and routine maintenance.<br>• As assigned, assist in implementation of new technologies and instrumentation.<br>• Document all quality control activities in accordance with laboratory requirements.<br>• Document all corrective actions taken when test systems deviate from the laboratory's established performance specifications.<br>• As assigned, prepare and store reagents, and maintain inventory reports/logs according to established processes.<br>• Identify issues related to equipment, instrumentation and/or reagents and immediately notify the general supervisor, technical supervisor, or director.<br>• Assists with Lab QA metrics and reporting.<br>• Follow the laboratory's procedures for specimen labeling, handling, preservation or fixation, processing or preparation, and transportation and storage of specimens.<br>• Assist in the performance of quality control procedures.<br>• May participate in training of new employees as assigned.<br>• As assigned, provide departmental support such as identification and retrieval of instrument and quality data, writing work instructions and performance qualification reports, copying, filing, data entry, and additional duties as needed.<br><br>OTHER RESPONSIBILITIES<br>• Ensuring that Quality Events such as incidents and deviations are proper documented, and for supporting/owning the immediate remediation and preventative actions<br>• Ensuring change requests are properly initiated, completed, and approved prior to the use of the assay, system, instrument, software, etc. being changed<br>• Maintaining up-to-date training records and ensuring training is complete prior to performing specific job functions<br>• Following approved and effective procedures to perform specific job functions, and ensuring procedures accurately reflect activities being performed[#video#https://www.youtube.com/watch?v=ggbnzRY9z8w{#400,300#}#/video#]