Medical Laboratory Scientist
IQVIA Holdings
Medical Laboratory Scientist
The Medical Laboratory Scientist performs high-complexity clinical laboratory testing to support patient care and clinical research activities. This role applies professional and technical expertise to generate accurate, timely, and reliable laboratory results in areas such as hematology, chemistry, immunology, and specialized testing. Work is performed in accordance with CLIA regulations, CAP standards, Good Clinical Laboratory Practice (GCLP), and applicable quality and safety requirements.
Essential Duties and Responsibilities
- Performs and reports high-complexity laboratory tests, both automated and manual, with minimal supervision.
- Demonstrates competency in laboratory principles, methodologies, and instrumentation across assigned testing areas.
- Maintains adequate inventory of reagents and supplies and prepares reagents as required.
- Identifies and reports irregularities, instrument issues, or factors that may affect test accuracy.
- Participates in assay validation, method improvements, and implementation of new technologies.
- Follows all safety procedures, uses required personal protective equipment, and reports safety concerns.
- Ensures compliance with CLIA, CAP, GCLP, and internal quality management systems.
- Adheres to quality control policies, documents QC activities, and maintains a clean, organized work environment.
- Maintains required training, competency assessments, and continuing education.
- Supports internal and external audits, inspections, and quality initiatives.
- Verifies quality control results and releases patient or study results in accordance with regulatory requirements.
- Assists with training and onboarding of laboratory personnel as needed.
- Performs duties in alignment with ICH E6 Good Clinical Practice guidelines when supporting clinical trials.
- Participates in special projects and performs additional tasks assigned by laboratory leadership.
Required Education and Experience
- Bachelor's degree in Medical Laboratory Science, Biology, Chemistry, or a related field.
- 0–5 years of clinical laboratory experience.
- Meets CLIA requirements for high-complexity testing personnel.
- National certification as MLS/MT (ASCP, AMT, or equivalent) required.
- Strong understanding of laboratory principles, testing methodologies, and regulatory standards.
- Proficiency in laboratory safety, infection control, and handling of hazardous chemicals.
- Ability to perform complex calculations, including averages, standard deviations, and QC metrics.
- Skilled in troubleshooting laboratory instruments and resolving testing issues.
- Proficient with Microsoft Excel, Word, and PowerPoint.
- Strong organizational, interpersonal, and communication skills.
- Ability to manage multiple tasks with accuracy and attention to detail.
- Ability to work effectively with colleagues, management, and external partners.
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