Senior Clinical Laboratory Specialist

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Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Grifols Laboratory Solutions in San Marcos, TX is seeking a Senior Clinical Laboratory Specialist. The Senior Clinical Laboratory Specialist provides hands‑on technical support for day‑to‑day clinical and manufacturing operations of Grifols 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. Senior Clinical Laboratory Specialist ensures that they perform their duties while maintaining regulatory compliance and with operational efficiency. The career path individual at this level is preparing to promote to a Lead position after 60+ months of experience and with management support and approval.

• Identify and communicate daily production, instrument, or test/reagent issues/problems to management
• Responsible that the lab is maintained 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
• Performs accessioning of clinical samples in the Laboratory Information System (LIS)
• Ensures accurate data transfer and electronic report generation, documents final results, submits results for review
• Uses LIS effectively to sign‑off test completion, communicates to management results are ready for review/release
• Documents and reports incorrect sample submissions to management; obtains clinical histories; communicates written and verbal reports to clients
• Assists with training new employees for routine, moderate, and high‑complexity tests; performs competency assessments of all staff; monitors staff performance and reports testing issues to management
• Assists in monitoring analyst performance against expectations
• Mentors lab staff to help maintain 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; creates drafts of new standard operating procedures (SOPs)
• Assists with strategic project testing; assists in summarizing data
• Participates in validation protocols; assists in the summary of validation data
• Assists management in scheduling laboratory equipment annual calibrations; delegates maintaining laboratory reagent and supplies (inventory) levels to staff
• Utilizes Microsoft tools to summarize daily, weekly, and monthly Quality metric data
• Supports Leads to document (Media Lab) deviations to SOPs, regulatory requirements, and company policies
• Utilizes Media Lab software to enter deviations and CAPA submissions/updates
• Maintains CE credits consistent with laboratory policy; evidence of management CE credits

• Contributes to laboratory organization and appearance. Maintains inventory in the lab and orders reagents as needed.

• Practical knowledge of immunohematology and molecular procedures including NAT testing.
• Profic…