Medical Technologist I
About the role
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At ICON, it's our people that set us apart.
As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry. Are you one of them? Suitable for persons looking for a career in clinical trials and laboratory testing.
The role:
Responsible for the quality and timelines of technical procedures, as well as their compliance with applicable company, CAP, and local regulatory agency testing requirements.
Perform technical assignments and testing and issue reports in accordance with written procedures. These should be processed within agreed turnaround times.
Enters and releases required information in the LIS, such as test results, comments, and quality control results in a timely manner with compliance to all regulatory requirements.
Adheres to written internal and external quality control procedures in order to ·ensure the quality of the results and maintain Corrective Action logs as appropriate.
Consults with laboratory management staff prior to reporting grossly abnormal results and when out of control test runs are encountered.
Responsible for the preparation quality control documentation, instrument and equipment maintenance documentation, performance of proficiency testing and compliance with all appropriate regulatory procedures and quality requirements in testing area.
Responsible for ensuring that reagents are maintained, prepared, stored and used in- a manner suitable for testing and documentation is kept to ensure adequate records are available in test area.
Performs the maintenance, calibration and validation of the instruments/assays assigned to the section according to written laboratory procedures.
Responsible for maintaining all paperwork and ensuring all records are kept up to date and stored safely as per standard operating procedures
Assists with responding to queries and quality issues, and participates in root cause analysis investigations as directed by laboratory management team.
Assists with the evaluation and validation of new procedures as required.
Assists in maintaining temperature monitoring system as required.
Reports to and is responsible to Supervisor/Manager for daily operation and evaluation of work performance.
Provides mentorship for training of Technologists, Technicians and Lab Assistants
What you need:
Basic working knowledge of and Compliance with all CAP and local agency regulatory requirements.
Demonstrated ability to manage multiple tasks with good organization skills and good attention to detail.
Ability to work as part of, and set the example of performance standards for a team.
Ability to work in conformance with standard operating procedure and conditions with a systematic approach to tasks committed to seeing things through to completion.
Demonstrated ability to keep accurate, legible records and recognize the need to handle these records and all other information in line with GCP/GLP/GDP.
Familiar with the operation of laboratory equipment with a demonstrated ability to check that equipment is functioning within its specifications and to respond appropriately to abnormalities.
Understands the basic principles of quality control, quality assurance and quality audits and outcomes.
Action oriented demonstrating the ability to handle work load demands resulting in the generation of large amounts of data and to trouble shoot issues timely when required.
Basic working knowledge of LIMS with the desire to achieve the mathematical, computational and instrumentation skills necessary to work and progress in Biomedical Science.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
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