Senior Clinical Laboratory Specialist
About The Position
Grifols Laboratory Solutions in San Marcos, Texas, is seeking a Senior Clinical Laboratory Specialist to provide hands-on technical support for daily clinical and manufacturing operations. The role includes performing patient molecular, serologic, and manufacturing tests; preparing and summarizing data for review and reporting; participating in method validations; and monitoring daily, weekly, and monthly quality control of equipment and systems. The specialist is expected to maintain regulatory compliance and operational efficiency. With 60 or more months of experience and management support and approval, an individual in this career path may be prepared for promotion to a Lead position. The position is performed in a plasma center or laboratory/manufacturing environment, with potential exposure to biological fluids, infectious organisms, electrical equipment, and extreme cold in plasma freezers. Personal protective equipment is required. Work includes a mix of sitting and standing, frequent hand and foot movements, occasional bending and twisting, and light lifting, with a maximum lift of 50 pounds. Occasional travel within the United States may be required.
Requirements
- Bachelor of Science degree in immunology, genetics, molecular biology, or a related field; one of the listed education pathways is required.
- At least 4 years of experience in a clinical or research laboratory environment; alternatively, an MS with 2 years of experience may be considered in lieu of a BS with 4 years, depending on the line of business.
- 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 all levels of staff and management and interface with clients.
- Proficiency in technical writing for regulated documents.
- Ability to promote teamwork and positive employee morale.
- Ability to perform the described laboratory work, including use of required PPE and handling samples, materials, and equipment.
Nice To Haves
- CLS (ASCP) certification or equivalent.
- Experience in a cGMP environment.
Responsibilities
- Identify and communicate daily production, instrument, or test/reagent issues to management.
- Keep the laboratory clean and organized, and contribute to its appearance and organization.
- Handle samples and materials using proper PPE and log incoming materials.
- Maintain technical competencies, keep annual competencies current, and align annual continuing education with competencies.
- Perform high-, moderate-, and simple routine tests.
- Accession clinical samples in the Laboratory Information System (LIS).
- Ensure accurate data transfer and electronic report generation; document final results and submit them for review.
- Use the LIS to sign off test completion and inform management when results are ready for review or release.
- Document and report incorrect sample submissions, obtain clinical histories, and communicate written and verbal reports to clients.
- Interview new employees and assist with their training for routine, moderate-, and high-complexity tests.
- Perform staff competency assessments, monitor staff performance, report testing issues to management, and help assess analyst performance against expectations.
- Mentor laboratory staff in adherence to SOPs, Quality System Essentials (QSE), good manufacturing practices (cGMP), and regulatory guidelines.
- Perform feasibility studies, assist management with new assay development, and draft new standard operating procedures (SOPs).
- Assist with strategic project testing and summarize data.
- Participate in validation protocols and assist with validation data summaries.
- Assist management in 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 from SOPs, regulatory requirements, and company policies in MediaLab.
- Use MediaLab to enter deviations and CAPA submissions or updates.
- Maintain continuing education credits in accordance with laboratory policy and provide evidence of management continuing education credits.
- Maintain laboratory inventory and order reagents as needed.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
