Grifols Shared Services North America, Inc Quality Specialist in Austin, Texas
For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care.
Headquartered in Barcelona, Spain, Grifols has over 20.000 employees in 30 countries. Grifols’ three main divisions - Bioscience, Diagnostic and Hospital - develop, manufacture and market innovative products and services available in more than 100 countries.
A leader in transfusion medicine, the Diagnostic Division is a global business focused on providing innovative solutions to help ensure the safety of the blood and plasma supply, detect human diseases and monitor therapies. The division advances patient care with diagnostic solutions to improve disease detection and management, and simplify laboratory operations.
Professional individual contributor that is primarily responsible for ensuring test results meet quality attributes and perform final approval and release of test results to laboratory customers. The job responsibilities of reviewing non-routine assignments, problem solving, and decision making increases with each level.
Primary responsibilities for role:
Ensure through test batch review that all source data meets quality attributes and cGMP regulation conformance prior to result reporting.
Responsible for final approval and release of test results to laboratory customers.
Evaluate environmental monitoring including investigating and addressing temperature and humidity deviations.
Review equipment re-qualifications and release instrumentation back into the production environment.
Review and approve critical testing reagents for use in production.
Review and approve calibrations and verifications performed on testing and general laboratory equipment ensuring acceptance criteria is met.
Accurately complete detailed documentation as required by established procedures and good documentation practices regulations.
Assist in maintaining organization and classification of archival records per standard operating procedure to ensure future retrieval.
Effectively communicate with personnel from various departments and escalate issues to Quality Management.
Works on problems of limited scope by following standard practices and procedures in analyzing situations or data.
Knowledge, Skills, and Abilities:
Must be able to work in a team environment and have interpersonal communication skills. Must be detail oriented and keep a high degree of focus even when performing routine tasks. Must be knowledgeable in computer operation in a Windows environment and able to follow company procedures to resolve routine issues.
Bachelor degree required. Science related field highly preferred.
Practical experience working in a cGMP regulated environment preferred.
Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level typically requires an Associate’s degree plus 2 years of experience, an equivalent could include 4 years of experience or a Bachelor's degree.
Learn more about Grifols
Req ID: 90207
Type: Regular Full-Time
Job Category: Health/Safety