Clinical Laboratory Specialist

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 for role:

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.

Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active nonexpired Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

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.

Location:NORTH AMERICA : USA : TX-San Marcos:custbuilding

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