Clinical Lab Specialist; 2nd shift

Position: Clinical Lab Specialist (2nd shift)

Overview

Clinical Lab Specialist (2nd shift) – San Marcos, TX – 12:00 PM - 08:30 PM CST – 06 Months

Responsibilities

• Provide hands-on technical support for day-to-day clinical and manufacturing operations of the laboratory.
• Perform patient molecular/serologic and manufacturing testing of samples; summarize data for review and reporting.
• Participate in method validations; monitor daily, weekly, and monthly QC of equipment and systems.
• Maintain regulatory compliance and operational efficiency.
• Perform duties related to tests, instruments, and reagents; identify potential instrument or reagent problems and escalate to Lead.
• Maintain a clean and organized workplace; handle PPE and material handling; log incoming materials.
• Maintain technical competencies; ensure annual competencies are up-to-date; align CE with competencies.
• Performs high-, mid-, and simple routine tests.
• Ensure accurate data transfer and electronic report generation; document final results; submit results for review.
• Perform accessioning of clinical samples in the Laboratory Information System (LIS); use LIS to sign off test completion and communicate readiness for review/release.
• Report incorrect sample submissions to management; communicate written reports to clients.
• Assist with training new employees for routine, moderate, and high-complexity tests; perform competency assessments of staff.
• Maintain strict adherence to SOPs, Quality System Essentials (QSE), good manufacturing practices (cGMP), and regulatory guidelines.
• Perform feasibility studies and assist management in the development of new assays.
• Assist with strategic project testing; summarize data; participate in validation protocols and in the summary of validation data.
• Perform equipment annual calibrations; utilize Microsoft tools to summarize quality metric data.
• Support deviation documentation (Media Lab) to SOPs; utilize Media Lab software to enter deviations and CAPA submissions/updates.
• Maintain CE credits consistent with laboratory policy.

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

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; ability to 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

No previous experience required. Twelve (12) months or less of experience in a clinical or research laboratory environment is a plus.

Occupational Demands

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 with 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.

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