Senior Clinical Laboratory Specialist

Grifols • San Marcos, TX

3d • Onsite

About The Position

Grifols Laboratory Solutions in San Marcos, Texas, is seeking a Senior Clinical Laboratory Specialist to provide hands-on technical support for day-to-day clinical and manufacturing operations. The role performs patient molecular/serologic and manufacturing testing, summarizes data for review and reporting, participates in method validations, and monitors equipment and systems quality control. The specialist is expected to maintain regulatory compliance and operational efficiency. This career-path level may prepare for promotion to a Lead position after 60 or more months of experience, with management support and approval.

The position also supports staff training and competency assessment, assay development and validation, laboratory inventory and equipment calibration coordination, quality metrics, and documentation of deviations and CAPA activity. Work takes place in a plasma center or laboratory/manufacturing environment, with occasional travel within the United States.

Requirements

• At least 4 years of experience in a clinical or research laboratory environment, or an MS with 2 years of experience in lieu of a BS with 4 years, depending on the line of business.
• A Bachelor of Science degree in immunology, genetics, molecular biology, or a related field.
• Practical knowledge of immunohematology and molecular procedures, including NAT testing.
• Proficiency in Microsoft Office Suites.
• Excellent organizational skills and ability to work on team projects.
• Strong written and verbal communication skills, including the ability to communicate with staff and management at all levels and interface with clients.
• Proficiency in technical writing for regulated documents.
• Ability to work independently and follow oral or written instructions, handle variable tasks and changing conditions, communicate sensitive or complex information, listen to and understand instructions, and apply abstract principles to complex conceptual issues.
• Ability to perform the physical and sensory functions described, including frequent hand and foot movement, precise finger coordination, hearing acuity, color perception, and correctable near and far vision.
• Ability to lift up to 50 pounds; light lifting of 15 pounds is also specified.
• Ability to work in a laboratory or manufacturing environment with potential exposure to biological fluids, infectious organisms, electrical equipment, and temperatures below 32°F in plasma freezers; required PPE includes protective eyewear, garments, gloves, and cold gear.

Nice To Haves

• CLS (ASCP) certification or equivalent.
• Experience in a cGMP environment is desirable.

Responsibilities

• Identify and communicate daily production, instrument, or test/reagent issues to management.
• Maintain a clean, organized laboratory and handle PPE, samples, and materials properly; log incoming materials.
• Maintain technical competencies, keep annual competencies current, and align annual continuing education with competencies.
• Perform high-, moderate-, and routine-complexity tests and accession clinical samples in the Laboratory Information System (LIS).
• Transfer data accurately, generate electronic reports, document final results, submit results for review, and use the LIS to sign off test completion and communicate readiness for review or release.
• Document incorrect sample submissions, obtain clinical histories, and communicate written and verbal reports to clients.
• Interview new employees and assist with their training in routine, moderate-, and high-complexity testing.
• Perform staff competency assessments, monitor staff performance, report testing issues to management, and help monitor analyst performance against expectations.
• Mentor laboratory staff in adherence to SOPs, Quality System Essentials (QSE), current good manufacturing practices (cGMP), and regulatory guidelines.
• Perform feasibility studies, assist management with developing assays, and draft new standard operating procedures.
• Assist with strategic project testing and summarize data.
• Participate in validation protocols and assist with summarizing validation data.
• Assist management with scheduling annual laboratory equipment calibrations and delegate maintenance of reagent and supply inventory levels to staff.
• Use Microsoft tools to summarize daily, weekly, and monthly quality metric data.
• Support Leads in documenting deviations and use MediaLab to enter deviations and CAPA submissions or updates.
• Maintain CE credits consistent with laboratory policy and provide evidence of management CE credits.
• Contribute to laboratory organization and appearance; maintain inventory and order reagents as needed.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior