About this role
<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="font-family:arial, helvetica, sans-serif">Shift: Day Shift</span></p> <p> </p> <p><span style="text-decoration:underline"><span style="font-family:arial, helvetica, sans-serif"><strong>Sr. Supervisor, Quality Assurance / Supervisor III, Quality Assurance:</strong></span></span></p> <p> </p> <p><strong><span style="font-family:arial, helvetica, sans-serif">Summary for Sr. Supervisor, QA:</span></strong></p> <p><span style="font-family:arial, helvetica, sans-serif">The Sr. Supervisor, Quality Assurance is responsible for supervising or overseeing a group of employees or a Quality Assurance system, program, project, etc. Participates in employee relations matters and is responsible for performance management in area of responsibility. May facilitate technical and non-technical training. Specific duties will depend on the assignment and may include; review of manufacturing or testing records, preparation or review of failure investigations, product/raw material sampling and/or testing, sampling/testing/data analysis of environmental monitoring samples and data, auditing, data analysis for stability, etc. The incumbent is a professional with high technical competency who leads project or discipline teams. May make Quality decisions for the team. The employee influences the direction of complex projects and communicates with all levels of employees. The incumbent and provides leadership and guidance to others. The employee may be responsible for training other employees and is a fully qualified professional. Serves as a delegate for the Quality Manager.</span></p> <p> </p> <p><strong><span style="font-family:arial, helvetica, sans-serif">Primary responsibilities for the Sr Supervisor QA role:</span></strong></p> <ul> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Supervise or oversee all aspects of a group of employees and/or a Quality system, program, or project.</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Ensures compliance with company policies and procedures and is responsible for optimum use of staff and technical capabilities within defined areas.</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Provides technical / non-technical expertise on quality-related matters.</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Provides guidance or may consult with manufacturing and internal regulatory departments on Quality matters. </span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Follows cGMP and department safety practices.</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Provides effective leadership to employees in Quality.</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Demonstrates high levels of values and integrity.</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">May consult with Quality Sr. Management regarding key decisions which need to be made within his/her defined area of responsibility.</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Demonstrated ability to independently make sound quality decisions</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Demonstrated ability to independently influence decision makers in other departments.</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Preparation/review/approval of regulatory documents</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Preparation of sections of the Annual Product Review as well as the overall APR</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Interacts regularly with members of management and as needed with regulatory officials.</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Other duties as assigned or as specified in the "Additional Responsibilities" section below may apply.</span></li> </ul> <p> </p> <p><strong><span style="font-family:arial, helvetica, sans-serif">Summary for Supervisor III QA:</span></strong></p> <p><span style="font-family:arial, helvetica, sans-serif">The Supervisor III, Quality Assurance is responsible for supervising or overseeing a group of employees or a Quality Assurance system, program, project, etc. Participates in employee relations matters and is responsible for performance management in area of responsibility. May facilitate technical and non-technical training. Responsibilities may also include advanced roles (such as author, reviewer, approver, administrator or coordinator) in all quality systems such as Change Control, Discrepancy Management, Quarantine, Batch Release, SAP, SAP Quality Module, Documentation, and Annual Product Reviews as well as provide Quality input for Validation projects, capital engineering projects, clinical studies, stability studies, ETPs, and Regulatory submissions. Responsible for representing Quality meetings. The employee may be responsible for training or supervising other employees and is a fully qualified professional who requires minimal supervision. </span></p> <p> </p> <p><strong><span style="font-family:arial, helvetica, sans-serif">Primary responsibilities for the Supervisor III QA role:</span></strong></p> <ul> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Supervise or oversee all aspects of a group of employees and/or a Quality system, program, or project.</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Ensures compliance with company policies and procedures and is responsible for optimum use of staff and technical capabilities within defined areas.</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Provides technical / non-technical expertise on quality-related matters.</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Provides guidance or may consult with manufacturing and internal regulatory departments on Quality matters. </span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Follows cGMP and department safety practices.</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Provides effective leadership to employees in Quality.</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Demonstrates high levels of values and integrity.</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">May consult with Quality Sr. Management regarding key decisions which need to be made within his/her defined area of responsibility.</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Demonstrated ability to independently make sound quality decisions</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Demonstrated ability to independently influence decision makers in other departments.</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Other duties as assigned or as specified in the "Additional Responsibilities" section below may apply.</span></li> </ul> <p> </p> <p><span style="font-family:arial, helvetica, sans-serif">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.</span></p> <p> </p> <p><span style="font-family:arial, helvetica, sans-serif"><strong><u>Education and Requirements</u></strong><strong>:</strong></span></p> <p><span style="font-family:arial, helvetica, sans-serif"><strong>Candidates for the Sr. Supervisor QA</strong>:<strong><u> </u></strong>BS/BA preferably in a STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 8 years relevant experience. A minimum of BA/BS <strong>is required</strong>.</span></p> <p><span style="font-family:arial, helvetica, sans-serif"><strong>Candidates for the Supervisor III-QA</strong>: BS/BA degree preferably in STEM (Science, Technology, Engineering, and Mathematics) discipline with a minimum of 6 years relevant experience, or equivalent combination of education and experience.</span></p> <p> </p> <p><span style="font-family:arial, helvetica, sans-serif"><strong><u>Knowledge, Skills, and Abilities</u></strong></span></p> <p><span style="font-family:arial, helvetica, sans-serif">Excellent communication skills (written and verbal) with familiarity with domestic (i.e. Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines. </span></p> <p> </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>