Clinical Laboratory Specialist

Grifols•San Marcos, TX

3d•Hybrid

About The Position

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; CLS (ASCP) or equivalent is a plus
4 years of experience in a clinical or research laboratory environment.
Experience in a cGMP environment is desirable.
Entry: No previous experience required.
Twelve (12) months or less of experience in a clinical or research laboratory environment is a plus

Nice To Haves

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