About this role
<p> <style type="text/css">table.MiTabla { max-width: 1020px;!important </style> </p> <table border="0" cellpadding="0" cellspacing="0"> <tbody> <tr> <td><img align="top/" alt="" src="https://staticweb.grifols.com/documents/675849/2554718/SSFF_10_LA.jpg/c7449196-fba0-6bcb-9d0d-f4c5652819f6?t=1636640424647"></td> </tr> <tr> <td> <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> </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 style="text-align:justify"><span style="color:#000000"><span style="font-size:14.0px"><span style="font-family:Verdana, Geneva, sans-serif">Taking care of people is at the heart of everything we do, and we start by taking care of you!!! A career at Grifols means experiencing our culture of caring. It’s an opportunity to do something meaningful, each day. It means sharpening your skills and growing your career. And it means working in an environment that celebrates diversity and is fair and inclusive!</span></span></span></p> <p> </p> <p><span style="color:#000000"><span style="font-size:14.0px"><span style="font-family:Verdana, Geneva, sans-serif"><strong><u>Summary:</u></strong></span></span></span></p> <p><span style="color:#000000"><span style="font-size:14.0px"><span style="font-family:Verdana, Geneva, sans-serif">The QA Sr. Specialist plays a pivotal role in laboratory operations, providing essential oversight and guidance, with a primary focus on clinical and manufacturing testing. Their multifaceted responsibilities encompass complaint handling, customer support, leading improvement initiatives, and meticulous document review. In addition, they serve as the key interface between quality assurance and auditing bodies, facilitating effective communication with both external auditors and internal departments. They may also supervise relevant tasks without formal evaluations.</span></span></span></p> <p> </p> <p><span style="color:#000000"><span style="font-size:14.0px"><span style="font-family:Verdana, Geneva, sans-serif"><strong><u>Primary Responsibilities for Role:</u></strong></span></span></span></p> <ul> <li><span style="color:#000000"><span style="font-size:14.0px"><span style="font-family:Verdana, Geneva, sans-serif">Independently handles complaints, investigations, performs root causes, assigning additional actions as necessary. </span></span></span></li> <li><span style="color:#000000"><span style="font-size:14.0px"><span style="font-family:Verdana, Geneva, sans-serif">Review/update/create SOPs to standardize current and new processes.</span></span></span></li> <li><span style="color:#000000"><span style="font-size:14.0px"><span style="font-family:Verdana, Geneva, sans-serif">Applies knowledge of regulatory bodies such as, CAP, CLIA, AABB, CFR, to identify, manage, and follow-up on Quality events.</span></span></span></li> <li><span style="color:#000000"><span style="font-size:14.0px"><span style="font-family:Verdana, Geneva, sans-serif">Leads cross-functional teams from internal departments/outside vendors to establish appropriate processes for product quality improvements. Ensures implementation/sustainability and monitors the field quality of the improvements. </span></span></span></li> <li><span style="color:#000000"><span style="font-size:14.0px"><span style="font-family:Verdana, Geneva, sans-serif">Represents QA interests on special projects related to area of expertise. </span></span></span></li> <li><span style="color:#000000"><span style="font-size:14.0px"><span style="font-family:Verdana, Geneva, sans-serif">Plan and conduct scheduled internal audits to assess compliance with FDA, ISO, MDR, and internal requirements. To include audit scheduling, investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions.</span></span></span></li> <li><span style="color:#000000"><span style="font-size:14.0px"><span style="font-family:Verdana, Geneva, sans-serif">Pro-actively investigate, identify, and implement best in class Quality Systems practices and implement/manage improvement projects within the organization; (CAPA, QMP, StAR, Lean, 5S).</span></span></span></li> <li><span style="color:#000000"><span style="font-size:14.0px"><span style="font-family:Verdana, Geneva, sans-serif">Drive awareness and compliance with applicable standard operating procedures/ work instructions / standards and regulations to meet, comply and champion all quality and regulatory commitments of</span></span></span><span style="color:#000000"><span style="font-size:14.0px"><span style="font-family:Verdana, Geneva, sans-serif">Interacts with regulatory and partner auditors/inspectors.</span></span></span></li> <li><span style="color:#000000"><span style="font-size:14.0px"><span style="font-family:Verdana, Geneva, sans-serif">Will also estimate, plan, schedule and review own and others’ work products and be accountable for the quality work delivered.</span></span></span></li> </ul> <p> </p> <p><span style="color:#000000"><u><span style="font-size:14.0px"><span style="font-family:Verdana, Geneva, sans-serif"><strong>Knowledge, Skills, and Abilities:</strong></span></span></u></span></p> <ul> <li><span style="color:#000000"><span style="font-size:14.0px"><span style="font-family:Verdana, Geneva, sans-serif">Advanced knowledge of complaint handling, testing instrument (hardware and software), QC, Manufacturing & Inventory processes.</span></span></span></li> <li><span style="color:#000000"><span style="font-size:14.0px"><span style="font-family:Verdana, Geneva, sans-serif">Working knowledge of QMS, Microsoft Word, Excel (or other data trending/analysis tools), Power Point and related functions including the formulation of graphs.</span></span></span></li> <li><span style="color:#000000"><span style="font-size:14.0px"><span style="font-family:Verdana, Geneva, sans-serif">Organizational skills, attention to detail and ability to prioritize in a fast-paced environment is essential. </span></span></span></li> <li><span style="color:#000000"><span style="font-size:14.0px"><span style="font-family:Verdana, Geneva, sans-serif">Must demonstrate<strong> </strong>initiative, independence, balanced assertiveness, flexibility, and team orientation. </span></span></span></li> <li><span style="color:#000000"><span style="font-size:14.0px"><span style="font-family:Verdana, Geneva, sans-serif">Ability to train and mentor within and outside the group.</span></span></span></li> <li><span style="color:#000000"><span style="font-size:14.0px"><span style="font-family:Verdana, Geneva, sans-serif">Can plan and coordinate own work according to higher-level project schedules. Including direction of contract personnel to ensure projects come to fruition in a timely manner.</span></span></span></li> </ul> <p> </p> <p><span style="color:#000000"><span style="font-size:14.0px"><span style="font-family:Verdana, Geneva, sans-serif"><strong><u>Education:</u></strong></span></span></span></p> <p><span style="color:#000000"><span style="font-family:Verdana, Geneva, sans-serif;font-size:14.0px">Requires BA or BS in biology, chemistry, biochemistry or any science related field.</span></span></p> <p><span style="color:#000000"><span style="font-size:14.0px"><span style="font-family:Verdana, Geneva, sans-serif">Quality certifications such as MT, MLS,CLS and ASQ or equivalent are a plus.</span></span></span></p> <p> </p> <p><span style="color:#000000"><span style="font-size:14.0px"><span style="font-family:Verdana, Geneva, sans-serif"><strong><u>Experience:</u></strong></span></span></span></p> <p><span style="color:#000000"><span style="font-family:Verdana, Geneva, sans-serif;font-size:14.0px"> 5-8 years related quality experience in complaint handling and investigation or a Master’s degree with 3-6 years of experience.</span></span></p> <p> </p> <p><span style="color:#000000"><span style="font-size:14.0px"><span style="font-family:Verdana, Geneva, sans-serif"><strong><u>Equivalency: </u></strong></span></span></span></p> <p><span style="color:#000000"><span style="font-family:Verdana, Geneva, sans-serif;font-size:14.0px">Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.</span></span></p> <p> </p> <p><u><span style="color:#000000"><span style="font-size:14.0px"><span style="font-family:Verdana, Geneva, sans-serif"><strong>More about us, benefits we provide you:</strong></span></span></span></u></p> <ul> <li><span style="color:#000000"><span style="font-size:14.0px"><span style="font-family:Verdana, Geneva, sans-serif">Salary in line with the market as well as an annual bonus target</span></span></span></li> <li><span style="color:#000000"><span style="font-size:14.0px"><span style="font-family:Verdana, Geneva, sans-serif">Paid Vacation, PTO, holidays</span></span></span></li> <li><span style="color:#000000"><span style="font-size:14.0px"><span style="font-family:Verdana, Geneva, sans-serif">Parental leave program</span></span></span></li> <li><span style="color:#000000"><span style="font-size:14.0px"><span style="font-family:Verdana, Geneva, sans-serif">Professional development opportunities (training, career development)</span></span></span></li> <li><span style="color:#000000"><span style="font-size:14.0px"><span style="font-family:Verdana, Geneva, sans-serif">Gym pass, Employees perks program</span></span></span></li> <li><span style="color:#000000"><span style="font-size:14.0px"><span style="font-family:Verdana, Geneva, sans-serif">401 (K) Retirement Plan (Grifols will match 100% on the first 4% of eligible compensation you contribute, and 50% on the next 2% of eligible compensation you contribute)</span></span></span></li> <li><span style="color:#000000"><span style="font-size:14.0px"><span style="font-family:Verdana, Geneva, sans-serif">Health insurance: Medical, Dental, Vision</span></span></span></li> <li><span style="color:#000000"><span style="font-size:14.0px"><span style="font-family:Verdana, Geneva, sans-serif">Travel accident insurance; Life and AD and D Insurance, Short- & Long-Term Disability Insurance</span></span></span></li> <li><span style="color:#000000"><span style="font-size:14.0px"><span style="font-family:Verdana, Geneva, sans-serif">Health Savings Account, Flexible Spending Account</span></span></span></li> <li><span style="color:#000000"><span style="font-size:14.0px"><span style="font-family:Verdana, Geneva, sans-serif">Critical Illness, Accident, Hospital Indemnity coverages</span></span></span></li> <li><span style="color:#000000"><span style="font-size:14.0px"><span style="font-family:Verdana, Geneva, sans-serif">Adoption benefits</span></span></span></li> </ul> <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><b>Location: NORTH AMERICA : USA : TX-San Marcos || NORTH AMERICA : USA : TX-Austin || NORTH AMERICA : USA : TX-San Antonio:[[cust_building]]</b> </p> <p> </p> <p><a href="http://www.grifols.com/es/web/international/home" target="_blank">Learn more about Grifols</a></p> <p> </p> <p> </p> <p> </p>