Senior Clinical Laboratory Specialist (528080)

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.

Summary:

The Senior 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. Senior Clinical Laboratory Specialist ensures that they perform their duties while maintaining regulatory compliance and with operational efficiency. The career path individual at this level is preparing to promote to a Lead position after 60 months of experience and with management support and approval.

Primary responsibilities for role:
Identify and communicate daily production instrument or test/reagent issues/problems to management
Responsible that the lab is maintained 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
Performs accessioning of clinical samples in the Laboratory Information System (LIS)
Ensures accurate data transfer and electronic report generation documents final results submits results for review
Uses LIS effectively to sign-off test completion communicates to management results are ready for review/release
Documents and reports incorrect sample submissions to management; obtains clinical histories; communicates written and verbal reports to clients
Interviews new employees
Assists with training new employees for routine moderate and high-complexity tests; performs competency assessments of all staff; monitors staff performance and reports testing issues to management
Assists in monitoring analyst performance against expectations
Mentors lab staff to help maintain 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; creates drafts of new standard operating procedures (SOPs)
Assists with strategic project testing; assists in summarizing data
Participates in validation protocols; assists in the summary of validation data
Assists management in scheduling laboratory equipment annual calibrations; delegates maintaining laboratory reagent and supplies (inventory) levels to staff
Utilizes Microsoft tools to summarize daily weekly and monthly Quality metric data
Supports Leads to document (MediaLab) deviations to SOPs regulatory requirements and company policies
Utilizes MediaLab software to enter deviations and CAPA submissions/updates
Maintains CE credits consistent with laboratory policy; evidence of management CE credits

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties responsibilities or requirements. Managers and supervisors may assign other duties as needed.

Additional Responsibilities:

Contributes to laboratory organization and appearance. Maintains inventory in the lab and orders reagents as needed.

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 technical writing for 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:

Consideration of an MS with 2 years experience in lieu of a BS with 4 years of experience.

Occupational Demands:

Work is performed in both a lab and an office environment. Frequently sits for 4-6 hours per day. Occasionally walks. Occasionally bends and twists neck. 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; ability to listen and understand instruction. Ability 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:USSMC - San Marcos Lab TX

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