Clinical Lab Specialist

Belcan; San Marcos (TX); On-site; USD 55,000 - 85,000; Full time

Job summary

Client Laboratory Solutions Inc. is seeking a Clinical Laboratory Specialist to provide hands-on technical support for day-to-day clinical and manufacturing operations.

You will perform molecular/serologic testing, summarize data for review, and participate in method validations while monitoring QC of equipment and systems. Role requires adherence to cGMP and regulatory guidelines, data integrity, and effective communication with management and clients.

Qualifications

• Practical knowledge of immunohematology and molecular procedures.
• Experience with NAT testing and regulated lab environments is a plus.
• Proficient in MS Office and technical writing; strong communication.

Responsibilities

• Perform tests, manage instruments and reagents; escalate issues promptly.
• Preserve a clean, organized workspace and proper PPE handling.
• Maintain competency records and align CE with annual requirements.
• Conduct high-/mid-complexity and routine tests with accurate data transfer.
• Accession clinical samples in LIS and sign off test results.
• Assist training and competency assessments for staff; support QA/QC.
• Follow SOPs, QSE, cGMP and regulatory guidelines; assist validations.
• Summarize validation data and support project testing; calibrate equipment.
• Use MediaLab to log deviations and CAPA submissions; track quality metrics.

Skills

Immunohematology

Molecular procedures

NAT testing

MS Office

Organizational skills

Teamwork

Written & verbal communication

Technical writing

Education

BSc in immunology/genetics/molecular biology or related field

CLS (ASCP) or equivalent is a plus

Tools

LIS

MediaLab

Job description

The Clinical Laboratory Specialist provides hands-on technical support for day-to-day clinical and manufacturing operations of Client Laboratory Solutions Inc. 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

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 demanads: 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 includes some repetitive action. Light to moderate lifting and carrying objects with a maximum lift of 50 Ibs. 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.