Quality Systems Associate

<p>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.</p> <div> <p><span><strong><span>Quality Systems Associate</span><span> </span></strong></span></p> <p> </p> </div> <div> <p><strong><span>Summary: </span><span> </span></strong></p> </div> <div> <div> <p><span> </span><span> </span></p> </div> <div> <p><span>Under the direct supervision of the Quality Systems Manager, perform quality assurance and Training functions to ensure compliance with internal and external regulations and protocol. </span><span> </span></p> </div> <div> <p><span> </span><span> </span></p> </div> <div> <p><strong><span>Primary responsibilities for role (level-specific responsibilities should be included in the chart below): </span><span> </span></strong></p> </div> <div> <p><span> </span><span> </span></p> </div> <div> <ul> <li> <p><span>Completes weekly review of equipment QC and maintenance records. </span><span> </span></p> </li> </ul> </div> <div> <ul> <li> <p><span>Documents, investigates, and performs root-cause analysis for deviations and customer complaints, specifically in how they related to product quality and/or donor safety. </span><span> </span></p> </li> </ul> </div> <div> <ul> <li> <p><span>Inspects and releases incoming supplies. Investigates and reports supplies have not met quality specifications and requirements prior to use. </span><span> </span></p> </li> </ul> </div> <div> <ul> <li> <p><span>Performs documentation review for unsuitable test results. </span><span> </span></p> </li> </ul> </div> <div> <ul> <li> <p><span>Assists the Quality Systems Manager to ensure that cGMP regulation, SOPs and regulatory requirements are followed. Duties include: </span><span> </span></p> </li> </ul> </div> <div> <ul> <li> <p><span>Under the direct supervision of the Quality Systems Manager, perform quality assurance and Training functions to ensure compliance with internal and external regulations and protocol. </span><span> </span></p> </li> </ul> </div> <div> <ul> <li> <p><span>Performs all product release activities. </span><span> </span></p> </li> </ul> </div> <div> <ul> <li> <p><span>Reviews lookback information and documentation.</span><span> </span></p> </li> </ul> </div> <div> <ul> <li> <p><span>Reviews waste shipment documentation. </span><span> </span></p> </li> </ul> </div> <div> <ul> <li> <p><span>Reviews unexpected plasmapheresis events including electronic donor chart and related documentation pertaining to exceptions occurring during the donation process. </span><span> </span></p> </li> </ul> </div> <div> <ul> <li> <p><span>Reviews electronic donor chart exceptions impacting donor eligibility/safety and/or product quality. </span><span> </span></p> </li> </ul> </div> <div> <ul> <li> <p><span>Reviews donor deferral notifications from competitor centers. </span><span> </span></p> </li> </ul> </div> <div> <ul> <li> <p><span>Reviews plasma processing documentation to ensure the proper freezing, storage and handling of product. </span><span> </span></p> </li> </ul> </div> <div> <p><span> </span></p> </div> <div> <p><strong><span>Quality Systems Associate </span><span> </span></strong></p> </div> </div> <div> <div> <p><span> </span><span> </span></p> </div> <div> <ul> <li> <p><span>Assist the Quality Systems Manager to ensure center training programs follow procedural requirements as defined in the donor center SOP and/or training programs documents. Duties include:</span><span> </span></p> </li> </ul> </div> <div> <ul> <li> <p><span>Creates, maintains, and audits training records and files to ensure compliance. </span><span> </span></p> </li> </ul> </div> <div> <ul> <li> <p><span>Performs employee training observations to ensure staff competency prior to releasing employees to work independently. </span><span> </span></p> </li> </ul> </div> <div> <ul> <li> <p><span>Conducts required training activities for Center Notifications, Corporate Directives, SOP changes, and initial SOP implementations. </span><span> </span></p> </li> </ul> </div> <div> <ul> <li> <p><span>On an occasional basis, when the Quality Systems Manager is absent, the Quality Systems Associate may be required to perform the following duties: </span><span> </span></p> </li> </ul> </div> <div> <ul> <li> <p><span>Reviews and approves of deferred donor reinstatement activities. </span><span> </span></p> </li> </ul> </div> <div> <ul> <li> <p><span>Assists with completion of the internal donor center audit. </span><span> </span></p> </li> </ul> </div> <div> <p><span> </span><span> </span></p> </div> <div> <p><strong><span>Summary: </span><