Laboratory Operation Specialist
6 days ago
**Essential Functions**
- Perform and document all specimen test procedures with accuracy, consistency and timeliness in accordance with current standard operating procedures (SOPs) and regulatory guidelines.
- Complete and prepare documentation in compliance with regulatory and corporate guidelines.
- Exercise good judgment in assessing whether test procedure is proceeding according to expectations and that results are within acceptable tolerances.
- Perform and document hands on training for other Laboratory Associates in areas of proven competency as assigned.
- Identify abnormal progress of test procedure, potential QC failures, or otherwise unusual results and escalate to Team Lead or Laboratory Management immediately.
- Act as a backup in any area of daily laboratory operations, as needed, and meet expectations of the laboratory associate job responsibilities in that area.
- Oversee the technology transfer of methods and SOPs from other groups within IQVIA such as Research and Development departments. This includes working with those departments to fill gaps that are identified to ensure the technology will be sustainable and scalable in laboratory operations.
- Produce technical documentation for laboratory assays and associated pipelines across all service areas in the business (i.e. Laboratory Ops, Quality Systems, Information Technology, and Finance).
- Identify and lead continuous process improvement initiatives for laboratory operations.
**Requirements**:
- Bachelors in any healthcare-related disciplines.
- At least 4 years’ experience in a regulated laboratory environment.
- Working knowledge of Good Laboratory Practices, Clinical Laboratory Improvement Amendments (CLIA) and any other governing regulatory requirements.
- Expertise with pipetting and other general molecular biology laboratory techniques.
- Proficiency with laboratory calculations regarding batches and specimens including but not limited to averages, means, standard deviations, and various quality control metrics.
- Excellent oral and written communication skills.
- Strong organizational skills, and close attention to detail are essential.
- Capable of handling multiple tasks simultaneously and independently.
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