Associate Stability Research Scientist II

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.

Description:

The incumbent will work in a supporting function to provide scientific and technical assistance in the research and development of plasma derived or recombinant proteins. The position provides support to the Stability Group by overseeing all facets of the stability program that are related to oversight of the stability chamber areas, storage, delivery and documentation of the sample inventory in order to maintain a compliant stability program for licensed products and developmental projects, ensuring on-going safety and quality of our products.

 

Responsibilities of this position include but are not limited to:

• Daily, maintain product inventory for active stability studies in accordance with all compliance requirements by assuring the accountability and delivery of all stability samples and associated documentation as well as the issuance of required documentation for testing.
• Coordinate with Packaging to acquire samples for batches to be placed into the stability program for evaluation.
• Maintain label printers in good working order to ensure ability to fulfill printing of labels for stability requests.
• Maintain and audit all sample labeling and documentation for accuracy and compliance with GMP.
• Facilitate delivery of stability samples for laboratory testing and coordinate with QC Sample Specialists and stability supervisors to correct any discrepancies associated with stability samples for testing.
• Possess experience necessary to note any uncharacteristic property of the stability samples, as the last viewer of samples before they are sent to the laboratory for testing.
• Track requests for additional samples.
• Generate and review monthly pull schedules for all stability testing for all active studies.
• Generate work orders for preventative maintenance and repairs for all equipment associated with stability incubators to prevent product loss due to equipment failure.  Ensure that the Preventative Maintenance program is executed in a timely manner.
• Assure compliance of all completed test request sheets for stability, as applicable.
• Experience in conducting a check-in process for receipt of data, when applicable, for data returned from the testing laboratories.
• Experience with entering test data into the stability databases, Stability System and/or SAP.
• Assist with filing of all stability records.
• Conduct investigations to document and resolve GMP discrepancies associated with sampling, labeling, and/or sample inventory.
• Remove samples from inventory and perform required documentation for completed stability studies.
• Initiate purchase orders and work orders for the Stability Group.
• Performs shipment of samples between sites.
• Trains Stability staff on sample handling and inventory procedures.
• Perform daily assessments of operation of the stability incubator and freezers.
• Conduct investigations for any excursions outside validated ranges (temperature for the stability incubators.
• Analyzes chamber temperature and humidity trends daily to evaluate for any issues.  Performs weekly, monthly, and annual reviews to ensure all equipment remaining compliant, and as a preventative measure to address chamber concerns prior to any impact on studies.

 

An understanding of ICH guidelines and GMP requirements set forth by regulatory agencies associated with the storage of Stability product is required. Good communication skills are needed to generate effective written and oral reports that are clear, accurate, and logical. The incumbent must possess excellent interpersonal and communication skills to interact effectively and promptly with all levels of th