About the job

Summary: The Clinical Laboratory Specialist provides hands-on technical support for day-to-day clinical and manufacturing operations. Responsibilities include: patient molecular/serologic and manufacturing testing of samples with the ability to perform and summarize data for review and reporting, participate in method validations, and monitor daily, weekly, and monthly QC of equipment and systems. A Clinical Laboratory Specialist ensures that they perform their duties while maintaining regulatory compliance and with operational efficiency.

Primary Responsibilities For Role

• Performs duties related to tests, instruments, and reagents. Identifies any potential instrument or regent problems and escalates to Lead.
• Maintains the workplace in a clean and organized manner
• Maintains proper PPE sample/material handling; logs all incoming materials
• Maintains technical competencies; ensures annual competencies are up-to-date; aligns annual CE with competencies
• Performs high-/mid-complexity, and simple routine tests
• Ensures accurate data transfer and electronic report generation, documents final results, submits results for review
• Performs accessioning of clinical samples in the Laboratory Information System (LIS)
• Uses LIS effectively to sign-off test completion, communicates to management results are ready for review/release
• Reports incorrect sample submissions to management; communicates written reports to clients
• Assists with training new employees for routine, moderate, and high-complexity tests; performs competency assessments of all staff
• Maintains strict adherence to SOPs, Quality System Essentials (QSE), good manufacturing practices (cGMP), and regulatory guidelines
• Performs feasibility studies and assists management in the development of new assays
• Assists with strategic project testing; assists in summarizing data
• Participates in validation protocols; assists in the summary of validation data
• Performs equipment annual calibrations
• Utilizes Microsoft tools to summarize daily, weekly, and monthly Quality metric data
• Supports Leads document (MediaLab) deviations to SOPs
• Utilizes MediaLab software to enter deviations and CAPA submissions/updates
• Maintains CE credits consistent with laboratory policy