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_06_GPO.jpg/a5d80af4-bb13-a8cd-d567-ea1e87192f07?t=1636640424362" 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><h2 style="text-align:center"><strong><span style="font-size:16.0px"><span style="font-family:Arial, Helvetica, sans-serif">This position in based in Clayton, NC.</span></span></strong></h2> <h2 style="text-align:center"><strong><span style="font-size:16.0px"><span style="font-family:Arial, Helvetica, sans-serif">1st shift - Monday - Friday 5:00am - 1:30pm</span></span></strong></h2> <h2 style="text-align:center"><strong><span style="font-size:16.0px"><span style="font-family:Arial, Helvetica, sans-serif"><u>Position requires flexibility in working some overtime and weekend shifts (every 3rd weekend). Shift may change with business needs. </u></span></span></strong></h2> <h1><span style="font-family:Calibri, sans-serif"><span style="font-size:11.0pt"><span style="color:#262626">The QA Supervisor coordinates and supervises the inspection and release of plasma lots for sale or further manufacture. Verifies critical systems and documentation associated with the destruction of plasma. Ensures compliance to approved procedures. This position has responsibility for the quality acceptance and release of plasma product shipments and supervision of the daily activities of the quality assurance staff.</span></span></span></h1> <ul> <li style="text-align:justify"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Supervises the daily activities of the quality assurance staff and ensures that required activities related to the receipt, storage, clearing, processing of Lookback Alerts, quarantine of unsuitable units, and release of Source Plasma for further manufacture or sales.</span></span></li> <li style="text-align:justify"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Responsible for the QA release of plasma from Plasma Logistic Center (PLC) and verifies that all shipment contents meet standard operating procedures, regulatory and customer requirements prior to release.</span></span></li> <li style="text-align:justify"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif"><span style="color:#262626">Reviews and verifies temperature documentation to ensure conformance to appropriate temperature specifications.</span></span></span></li> <li style="text-align:justify"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Investigates and documents deviations noted because of routine compliance reviews, internal and external audits and customer complaints.</span></span></li> <li style="text-align:justify"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Participates in the writing and revision of policies and procedures related to Source Plasma at the facility.</span></span></li> <li style="text-align:justify"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Monitors Plasma Operations to maintain compliance with all applicable regulations, cGMPs and CFRs. Participates in internal audit for the facility. Interfaces with multiple levels of management and various support and service groups internally and externally.</span></span></li> <li style="text-align:justify"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Trains current and new employees maintains and updates training records of the QA staff. Supervises the activities of quality assurance staff including hiring, performance management, disciplinary action, and professional development.</span></span></li> <li style="text-align:justify"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Meet quality assurance and company financial objectives by monitoring department costs.</span></span></li> </ul> <p style="text-align:justify"> </p> <p style="text-align:justify"><strong><u><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">EDUCATION AND EXPERIENCE</span></span></u></strong></p> <ul> <li style="text-align:justify"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Bachelor’s degree in life sciences or related field ideal.</span></span></li> <li style="text-align:justify"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Typically requires a minimum of 5 years of Quality Assurance related experience and 3 years working in pharmaceuticals. Project or technical leadership experience required. Supervisory or management experience preferred.</span></span></li> </ul> <p style="text-align:justify"> </p> <p style="text-align:justify"><strong><u><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">KNOWLEDGE, SKILLS AND ABILITIES</span></span></u></strong></p> <p style="text-align:justify"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Strong analytical, organizational and interpersonal skills with extensive knowledge of cGMPs as specified in the CFR/USP and EP Pharmacopeia / ICH and ISO Guidelines. Excellent written/verbal/leadership skills must be able to make sound decisions that may affect the quality purity or efficacy or a drug product. Anticipates and identifies problems; analyzes situations; consider alternatives; monitor and evaluates results in a systematic manner. </span></span></p> <p style="text-align:justify"> </p> <p style="text-align:justify"><strong><u><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">OCCUPATIONAL DEMANDS</span></span></u></strong></p> <p style="text-align:justify"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">Ability to read and review documents for up to four (4) hours at a time. Ability to stand for extended periods of time - up to four (4) hours at a time. Ability to lift, tug, pull up to fifty (50) pounds. Ability to travel via automobile and/or airplane.</span></span></p> <p style="text-align:justify"><span style="font-size:11.0pt"><span style="font-family:Calibri, sans-serif">#Biomatusa</span></span></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>