Clinical Lab Specialist

• Bachelors of Science Degree in immunology, genetics, molecular biology, or related field and 12 months or less of experience in a clinical or research laboratory environment
• At least 16 semester hours of additional graduate-level coursework in chemical, biological, clinical, or medical laboratory science, or medical technology

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 reagent 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 (Media Lab) deviations to SOPs.
• Utilizes Media Lab software to enter deviations and CAPA submissions/updates.
• Maintains CE credits consistent with laboratory policy.

Knowledge, Skills, and Abilities
:

• Practical knowledge of immunohematology and molecular procedures, including NAT testing.
• Proficient in MS Office Suites.
• Excellent organizational skills.
• Ability to work on team projects.
• Strong written and verbal communication skills.
• Must be able to communicate with all levels of staff and management and interface with clients.
• Proficient in technical writing for inclusion in regulated documents.
• Promotes teamwork and has a positive employee morale.

Education
:

One of the following required:

• Bachelors of Science Degree in immunology, genetics, molecular biology, or related field.
• CLS (ASCP) or equivalent is a plus.

Experience
:

• Entry level; no previous experience required.
• Twelve (12) months or less of experience in a clinical or research laboratory environment is a plus.
• Work is performed in both a lab and an office environment.
• Frequently sits a total of 4–6 hours per day.
• Occasionally walks.
• Occasionally bends and twists neck.
• Holds and uses calibrated micropipettors for extended time periods that include some repetitive action.
• Light to moderate lifting and carrying objects with a maximum lift of 50 lbs.
• Some occasional travel within the United States.
• Able to communicate complex information and ideas so others will understand.
• Able to listen and understand instructions.
• Able to apply abstract principles to solve complex conceptual issues.