Grifols Shared Services North America, Inc Quality Specialist (2nd Shift) in Austin, Texas
Grifols is a global healthcare company whose mission is to improve the health and well-being of people. Our three divisions –Bioscience, Diagnostic and Hospital–develop, produce and market our innovative products and services to medical professionals in more than 100 countries.
We are committed to fostering an environment that creates continuous learning opportunities and encourages professional development and growth. As a company devoted to improving the health and well-being of people, we are looking for talented professionals worldwide. Make a difference and join us in this challenging and rewarding enterprise.
Under direct supervision, support the quality system by ensuring that systems and elements that influence the quality of test results are working as expected.
● Perform Test Batch Review and Release for final result reporting.
● Perform Shipment/Lot QA release functions.
● Perform environmental monitoring
● Perform review of executed validations.
● Perform review of equipment re-qualifications, calibrations and maintenance documentation
● Perform semi-monthly review of QC logs
● Accurately complete detailed documentation as required by established procedures
● Assist in supporting internal and third party audits, document archiving and QIR investigations as needed
● Escalate quality issues to management
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.
Bachelor degree required. Science related field highly 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 requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.
Must be able to work in a team environment. Must be detail oriented and keep a high degree of focus even when performing routine tasks. Practical experience working in a cGMP regulated environment preferred.
Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate complex 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 with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Ability to apply abstract principles to solve complex conceptual issues.
Learn more about Grifols at http://www.grifols.com/es/web/international/home