Clinical Laboratory Specialist
About The Position
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.
Requirements
- 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.
- Bachelors of Science Degree in immunology, genetics, molecular biology, or related field
- 4 years of experience in a clinical or research laboratory environment.
- Experience in a cGMP environment is desirable.
Nice To Haves
- CLS (ASCP) or equivalent is a plus
- Entry: No previous experience required. Twelve (12) months or less of experience in a clinical or research laboratory environment is a plus
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
- Contributes to laboratory organization and appearance. Able to use appropriate software systems to place online reagent/maintenance orders.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
