Senior Clinical Laboratory Specialist

Senior Clinical Laboratory Specialist Location: TX-San Marcos, US Contract Type: Regular Full-Time Area: MANUFACTURING Req Id: 547117 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. Location: San Marcos, Texas Grifols Laboratory Solutions in San Marcos, TX is seeking a Senior Clinical Laboratory Specialist. 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

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: Bachelor of Science Degree in immunology, genetics, molecular biology, or related field; CLS (ASCP) or equivalent is a plus.

Experience:

• A minimum of 4 years’ experience in a clinical or research laboratory environment. Experience in a cGMP environment is desirable.
• Equivalency: Depending on the line of business consideration of an MS with 2 years’ experience in lieu of a BS with 4 years of experience.

Occupational Demands: Work is performed in a plasma center or laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office and laboratory equipment. Exposure to extreme cold below 32 degrees F while performing functions in plasma freezers. Personal protective equipment required such as protective eyewear, garments, gloves and cold-gear. Work is performed both standing and sitting for up to 2 to 4 hours per day each. The position does require bending and twisting of neck up from 1 to 2 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Frequent foot movement; may squat, crouch or sit on one's heels on rare occasion. Occasionally walks, bends and twists at waist. Light lifting of 15lbs. with a maximum lift of 50lbs. May reach below shoulder height. Hearing acuity essential. Color perception/discrimination, near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently and within guidance of oral or written instructions. Performs a wide range of tasks as dictated by variable demands and changing conditions. Relates sensitive information to diverse groups. 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 Learn more about Grifols Nearest Major Market: San Diego