Senior Clinical Laboratory Specialist

Grifols, S.A; San Marcos (TX); On-site; USD 65,000 - 85,000; Full time

Job summary

Grifols, S.A. in Texas is seeking a qualified laboratory professional to perform a range of immunohematology and molecular procedures in a regulated, cGMP environment. You will work with LIS and Medical Lab information systems, ensuring accurate data and timely reporting.

The role requires a BS in a related field, ASCP CLS or equivalent is a plus, and at least 4 years in a clinical or research lab. Strong written and verbal communication and teamwork are essential.

Qualifications

• BS in immunology, genetics, molecular biology, or related field.
• CLS (ASCP) or equivalent is a plus.
• 4 years in clinical or research lab.
• Experience in a cGMP environment desirable.

Responsibilities

• Perform tests, instruments, and reagents; identify problems and escalate.
• Maintain clean, organized workspace.
• Manage PPE/sample handling; log materials.
• Ensure annual competencies and CE alignment.
• Perform high-/mid-/simple routine tests.
• Ensure data transfer and electronic report generation; document results.
• Accession clinical samples in the LIS and sign-off in LIS.
• Train new employees and assess competency.
• Maintain adherence to SOPs, QSE, cGMP, and regulatory guidelines.
• Assist with validation and development of new assays.
• Equipment annual calibrations; pharmaceutical-grade practices.

Skills

Immunohematology

Molecular procedures

MS Office

Teamwork

Written communication

Verbal communication

Technical writing

Education

BSc immunology

CLS (ASCP) or equivalent

Tools

LIS software

MediaLab

Job description

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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.

Primary responsibilities for role:

• Perform 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.