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Quality Associate II/III (NC-Clayton, US) @ GRIFOLS, S.A.

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<style type="text/css"> table.MiTabla { max-width: 1020px;!important </style> <table border="0" cellspacing="0" cellpadding="0"> <tbody> <tr> <td><img src="https://staticweb.grifols.com/documents/675849/2554718/SSFF_02_CLAYTON.jpg/4f428334-9cb2-1679-ffa2-c56b3cd1097b?t=1636640425916" alt="" align="top/"></td> </tr> <tr> <td> <p style="text-align:justify">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> </td> </tr> <tr> <td><img src="https://staticweb.grifols.com/documents/675849/2554709/SuccesFactors_1020x93_jobposting_line_test.png/e2cffc87-a707-9e08-b5ef-081cae1f1ecf?t=1636640341637" width="100%"></td> </tr> </tbody> </table><p> </p> <p><span style="color:#000000;font-size:12.0pt"><span style="font-family:Arial, Helvetica, sans-serif"><strong>Schedule:</strong> Day Shift</span></span></p> <p> </p> <p><span style="color:#000000;font-size:12.0pt"><span style="font-family:Arial, Helvetica, sans-serif"><strong><u>Job Description</u></strong></span></span></p> <p> </p> <p><span style="color:#000000;font-size:12.0pt"><span style="font-family:Arial, Helvetica, sans-serif">The Quality Associate II/III provides routine technical support for various tasks, assignments, and projects in the QA Fractionation business unit. This includes pre-pooling release of plasma pool shipments, assessment of plasma post donation &amp; lookback alerts, preparation of pool sample shipments to the PEI, and manufacturing record review for Pooling through Fractionation Batch Release to support department cycle time goals. Other tasks performed by the Quality Associate II/III may also include those associated with release and shipment of Contract Fractionation batches and Quarantine of intermediates. </span></span></p> <p> </p> <p><span style="font-size:12.0pt"><u><strong><span style="color:#000000"><span style="font-family:Arial, Helvetica, sans-serif">Responsibilities include:</span></span></strong></u></span></p> <p> </p> <ul> <li style="font-size:12.0pt"><span style="color:#000000;font-size:12.0pt"><span style="font-family:Arial, Helvetica, sans-serif">Collects, reviews and may analyze data</span></span></li> <li style="font-size:12.0pt"><span style="color:#000000;font-size:12.0pt"><span style="font-family:Arial, Helvetica, sans-serif">Makes decisions within a well-defined area that may influence the department goals</span></span></li> <li style="font-size:12.0pt"><span style="color:#000000;font-size:12.0pt"><span style="font-family:Arial, Helvetica, sans-serif">Coordinates work assignments</span></span></li> <li style="font-size:12.0pt"><span style="color:#000000;font-size:12.0pt"><span style="font-family:Arial, Helvetica, sans-serif">Addresses and resolves problems according to written procedures (eg. SOP) or practice</span></span></li> <li style="font-size:12.0pt"><span style="color:#000000;font-size:12.0pt"><span style="font-family:Arial, Helvetica, sans-serif">Communicates effectively and promptly</span></span></li> <li style="font-size:12.0pt"><span style="color:#000000;font-size:12.0pt"><span style="font-family:Arial, Helvetica, sans-serif">Demonstrates high levels of values and integrity</span></span></li> <li style="font-size:12.0pt"><span style="color:#000000;font-size:12.0pt"><span style="font-family:Arial, Helvetica, sans-serif">Follows cGMP and department safety practices</span></span></li> <li style="font-size:12.0pt"><span style="color:#000000;font-size:12.0pt"><span style="font-family:Arial, Helvetica, sans-serif">May train other employees</span></span></li> </ul> <p> </p> <p><span style="font-size:12.0pt"><u><strong><span style="color:#000000"><span style="font-family:Arial, Helvetica, sans-serif">Additional responsibilities may also include:</span></span></strong></u></span></p> <p> </p> <ul> <li style="font-size:12.0pt"><span style="color:#000000;font-size:12.0pt"><span style="font-family:Arial, Helvetica, sans-serif">Execute assignments of medium complexity</span></span></li> <li style="font-size:12.0pt"><span style="color:#000000;font-size:12.0pt"><span style="font-family:Arial, Helvetica, sans-serif">Develop solutions to defined problems</span></span></li> <li style="font-size:12.0pt"><span style="color:#000000;font-size:12.0pt"><span style="font-family:Arial, Helvetica, sans-serif">Collect, review and analyze data to generate department reports</span></span></li> <li style="font-size:12.0pt"><span style="color:#000000;font-size:12.0pt"><span style="font-family:Arial, Helvetica, sans-serif">Communicate effectively at all levels of the organization, supporting department objectives and management decisions</span></span></li> <li style="font-size:12.0pt"><span style="color:#000000;font-size:12.0pt"><span style="font-family:Arial, Helvetica, sans-serif">Perform roles and/or tasks associated with one or more Quality System function such as Batch Release, SAP Quality Module, Documentation, Change Control, Discrepancy Management, Quarantine, and Annual Product Reviews</span></span></li> <li style="font-size:12.0pt"><span style="color:#000000;font-size:12.0pt"><span style="font-family:Arial, Helvetica, sans-serif">May also provide Quality support for validation, capital projects, ETPs, Regulatory submissions, or other studies</span></span></li> </ul> <p> </p> <p><span style="color:#000000;font-size:12.0pt"><span style="font-family:Arial, Helvetica, sans-serif">Some tasks will be performed in a gowned, classified area including in +5°C or colder environments.</span></span></p> <p> </p> <p><span style="color:#000000;font-size:12.0pt"><span style="font-family:Arial, Helvetica, sans-serif"><strong><u>Knowledge, Skills, and Abilities</u></strong></span></span></p> <p> </p> <p><span style="color:#000000;font-size:12.0pt"><span style="font-family:Arial, Helvetica, sans-serif">Successful candidates should have excellent communication skills (written and verbal), attention to detail, and the ability to be flexible and adapt to sudden changes in priorities and deadlines. He/she must have the ability to multi-task, work well under time constraints, and demonstrate consistent application of technical knowledge. He/she should also have basic knowledge/understanding of domestic (i.e. Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines.</span></span></p> <p> </p> <p><span style="color:#000000;font-size:12.0pt"><span style="font-family:Arial, Helvetica, sans-serif">Preference will be given to candidates with knowledge of plasma release, pooling and/or fractionation processes and/or experience reviewing and approving others’ work such as batch records, test data, reports etc.</span></span></p> <p> </p> <p><span style="color:#000000;font-size:12.0pt"><span style="font-family:Arial, Helvetica, sans-serif"><strong><u>Required Education</u></strong></span></span></p> <p> </p> <p><span style="color:#000000;font-size:12.0pt"><span style="font-family:Arial, Helvetica, sans-serif"><strong>Quality Associate II (M06)</strong>: BS/BA degree preferably in STEM (Science, Technology, Engineering, and Mathematics) discipline with a minimum of 2 years relevant experience, or equivalent combination of education and experience.</span></span></p> <p> </p> <p><span style="color:#000000;font-size:12.0pt"><span style="font-family:Arial, Helvetica, sans-serif"><strong>Quality Associate III (M07)</strong>: BS/BA degree preferably in STEM (Science, Technology, Engineering, and Mathematics) discipline with a minimum of 3 years relevant experience, or equivalent combination of education and experience.</span></span></p> <p> </p><p style="margin-bottom:11.0px"> </p> <p style="margin-bottom:11.0px"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Third Party Agency and Recruiter Notice:</span></span></p> <p style="margin-bottom:11.0px"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">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.</span></span></p> <p style="margin-bottom:11.0px"> </p> <p style="margin-bottom:11.0px"><strong><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">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.</span></span></strong></p> <p> </p> <p><img src="https://staticweb.grifols.com/documents/675849/2554709/SuccesFactors_1020x93_jobposting_line_test.png/e2cffc87-a707-9e08-b5ef-081cae1f1ecf?t=1636640341637" width="100%"></p> <p><strong>Location: NORTH AMERICA : USA : NC-Clayton:USNC0002 - Clayton</strong> </p> <p> </p> <p><a href="https://www.grifols.com/en/what-we-do" target="_blank" rel="noopener">Learn more about Grifols</a></p> <p> </p>

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