Clinical Laboratory Specialist

Grifols, S.A; San Marcos (TX); On-site; USD 75,000 - 105,000; Full time

Job summary

Grifols 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 patient molecular/serologic testing and assist in data review for reporting, with involvement in method validations and QC of equipment and systems. The role requires experience in immunohematology and molecular procedures, proficiency with MS Office, and strong written and verbal communication.

Qualifications

• Requires a Bachelors of Science in immunology, genetics, molecular biology or related field; CLS (ASCP) or equivalent is a plus
• 4 years of experience in a clinical or research lab; cGMP experience desirable
• Proficient in MS Office Suites; strong data handling and technical writing skills

Responsibilities

• Performs high-/mid-/simple routine tests and manages instruments and reagents
• Maintains PPE handling and logs materials
• Performs LIS accessioning and ensures data transfer and reporting
• Assists with validation protocols and data summaries
• Maintains regulatory compliance and QA/QC metrics
• Trains and assesses competency of staff
• Supports deviations and CAPA documentation in MediaLab

Skills

Immunohematology

Molecular procedures

MS Office

Teamwork

Verbal and written communication

Technical writing

Education

Bachelors of Science in immunology/genetics/molecular biology

CLS (ASCP) or equivalent (plus)

Tools

MediaLab

Job description

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.

The 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. A Clinical Laboratory Specialist ensures that they perform their duties while maintaining regulatory compliance and with operational efficiency.

Primary Responsibilities

• 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

Additional Responsibilities

Contributes to laboratory organization and appearance. Able to use appropriate software systems to place online reagent/maintenance orders.

Knowledge, Skills & 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, 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

4 years of experience in a clinical or research laboratory environment. Experience in a cGMP environment is desirable.

Equivalency

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 that includes 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.

Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.