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We are seeking a Clinical Laboratory Specialist to join a dynamic laboratory team supporting clinical and manufacturing operations. This is a great opportunity for early-career professionals looking to build hands-on experience in molecular and serologic testing within a regulated environment. In this role, you’ll perform laboratory testing, analyze and report data, support validation activities, and help maintain high-quality and compliance standards across operations.
Job Responsibility:
Perform laboratory testing across high-, moderate-, and low-complexity assays
Analyze, document, and report test results with accuracy
Accession and track samples using a Laboratory Information System (LIS)
Maintain compliance with SOPs, cGMP, and quality standards
Support validation studies, feasibility assessments, and new assay development
Conduct routine quality control and assist with equipment calibration
Investigate and report sample discrepancies or technical issues
Maintain a clean, organized, and compliant lab environment
Document deviations and CAPA activities
Assist with training and competency assessments for team members
Requirements:
Bachelor’s degree in Immunology, Genetics, Molecular Biology, or related field
Exposure to clinical or research lab environments (internships or up to 12 months preferred)
Knowledge of molecular and immunohematology testing (NAT testing a plus)
Strong attention to detail and organizational skills
Effective communication and teamwork abilities
Proficiency in Microsoft Office tools
Nice to have:
CLS (ASCP) certification or equivalent
Experience working in regulated environments (GMP, clinical labs, etc.)
Technical writing experience for regulated documentation