QA Document Control Specialist

<p><span style="font-size: 10pt;"><span class="TextRun SCXW2579736 BCX8" lang="EN-US" data-contrast="none"><span class="NormalTextRun SCXW2579736 BCX8"><strong>Want to Make a Real Impact? Join Our QA Document Control Specialist Talent Pool!</strong></span></span></span></p> <p><span style="font-size: 10pt;">The Quality Assurance Document Control Specialist role is a position with responsibilities for supporting the document management process within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will ensure compliance within the document management system, document storage and retention, and document issuance and reconciliation.</span></p> <h2><span style="font-size: 10pt;"><strong><span style="font-size: 12pt;">What can you expect?</span> </strong></span></h2> <ul> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Responsible for managing the document control systems and processes for the site.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Serve as a Document Control reviewer for new and revised procedures and documents to ensure compliance with global and site procedures.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Support Document Management system users with workflow handling and electronic system usage.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Manage the periodic review process for procedures.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Issuance of batch related documentation in support of GMP manufacturing.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Reconcile GMP documentation following document lifecycle requirements.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Creation and issuance of GMP logbooks.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Responsible for storage and archival of GMP documents and batch related records.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Review and approve SOPs, and other documentation.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Drive continuous improvement.</span></li> <li style="font-size: 10pt;"><span style="font-size: 10pt;">Have advanced computer skills to increase department's productivity, as well as broadening technical and scientific knowledge.</span></li> </ul> <h2><span style="font-size: 12pt;"><strong>Who are we looking for? </strong></span></h2> <h3><span style="font-size: 10pt;"><strong>Education:&nbsp;</strong></span></h3> <ul> <li><span style="font-size: 10pt;">You are an undergrad, have a secondary degree or equivalent through experience.</span></li> </ul> <h3><span style="font-size: 10pt;"><strong>Experience:</strong></span></h3> <ul> <li><span style="font-size: 10pt;">Not required.</span></li> <li><span style="font-size: 10pt;">It is preferable that the candidate has experience working in a GMP environment, but this is not a must.</span></li> </ul> <h3><strong><span style="font-size: 10pt;">Language:</span></strong></h3> <ul> <li><span style="font-size: 10pt;">Dutch and technical English</span></li> </ul> <h3><span style="font-size: 10pt;"><strong>Strengths:&nbsp;</strong></span></h3> <div> <ul> <li> <div>Strong written and verbal communication skills</div> </li> <li> <div>Strong analytical problem‑solving and conflict‑resolution skills</div> </li> <li> <div>Highly organized, detail‑oriented, and able to multitask effectively</div> </li> <li> <div>Ability to manage shifting priorities and meet critical deadlines in a fast‑paced, dynamic environment</div> </li> <li> <div>Flexible and highly motivated, including flexibility in work schedule</div> </li> <li> <div>Effective interpersonal skills with the ability to communicate across all levels of the organization</div> </li> <li> <div>Ability to work independently with a high degree of accountability</div> </li> </ul> <h3><span style="font-size: 10pt;"><strong>Expertise:</strong></span></h3> <div> <ul> <li>GxP Quality System knowledge, including relevant regulations and guidances (e.g. 21 CFR, ICH Q10, EU GDP/GMP, Part 11 / Annex 11, PIC/S, MHRA)</li> <li>Operational experience with electronic quality systems</li> <li>Experience with Document Management Systems (e.g. TruVault, Veeva)</li> <li>Proficient knowledge of Microsoft Office applications (Outlook, Excel, Word, PowerPoint)</li> </ul> </div> </div> <h2><span style="font-weight: bold;"><span style="font-size: 12pt;">What do we offer you?</span>&nbsp;</span></h2> <ul style="margin-top: 0in; margin-bottom: 0in;" type="disc"> <li style="margin-top: 0px; margin-bottom: 0px; vertical-align: middle; font-family: helvetica, arial, sans-serif;"><span style="font-family: helvetica, arial, sans-serif;"><span lang="en-BE" style="font-size: 10pt;">A meaningful job with an excellent work-life balance. You will work 4 days, followed by 4 days at home</span><span lang="en-BE" style="font-size: 10pt;">.</span></span></li> <li style="margin-top: 0px; margin-bottom: 0px; vertical-align: middle; font-family: helvetica, arial, sans-serif;"><span style="font-family: helvetica, arial, sans-serif; font-size: 10pt;">A supportive and innovative work environment that encourages learning and personal development.&nbsp;</span></li> <li style="margin-top: 0px; margin-bottom: 0px; vertical-align: middle; font-family: helvetica, arial, sans-serif;"><span style="font-family: helvetica, arial, sans-serif; font-size: 10pt;">The opportunity to work with people from all over the world.&nbsp;</span></li> <li style="margin-top: 0px; margin-bottom: 0px; vertical-align: middle; font-family: helvetica, arial, sans-serif;"><span style="font-family: helvetica, arial, sans-serif; font-size: 10pt;">You start working through interim contracts. After 6 months you'll receive a permanent contract.</span></li> <li style="margin-top: 0px; margin-bottom: 0px; vertical-align: middle; font-family: helvetica, arial, sans-serif;"><span style="font-family: helvetica, arial, sans-serif; font-size: 10pt;">An attractive salary package with numerous benefits, including additional statutory vacations, meal vouchers of €7/day , group and hospitalization insurance once you start your permanent contract, double vacation pay, and performance bonuses.&nbsp;</span></li> </ul> <h2><span style="font-size: 12pt;"><strong>About Legend Biotech</strong></span></h2> <p><span style="font-size: 10pt;"><span data-contrast="auto">Legend Biotech is a global biotechnology company dedicated to developing, manufacturing, and commercializing innovative and life-saving cell therapies for the treatment of chronic and life-threatening diseases, such as cancer.</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335559738&quot;:120,&quot;335559739&quot;:120,&quot;335559740&quot;:240}">&nbsp;</span></span></p> <p><span style="font-size: 10pt;"><span data-contrast="auto">The company was founded in 2014 and is headquartered in Somerset, New Jersey. Legend Biotech now employs over 2,400 people across six global manufacturing sites. Two of these sites are in Ghent: Obelisc (Technology Park Zwijnaarde) and Tech Lane (Eilandje Zwijnaarde).</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335559738&quot;:120,&quot;335559739&quot;:120,&quot;335559740&quot;:240}">&nbsp;</span></span></p> <p><span style="font-size: 10pt;"><span data-contrast="auto">In Ghent, Legend Biotech focuses on the production of advanced CAR-T cell therapies for the treatment of multiple myeloma, in close collaboration with Johnson &amp; Johnson.</span><span data-ccp-props="{&quot;201341983&quot;:0,&quot;335559738&quot;:120,&quot;335559739&quot;:120,&quot;335559740&quot;:240}">&nbsp;</span></span></p> <p>&nbsp;</p> <p><span style="font-size: 10pt;">#LI-AG1</span></p><div class="content-conclusion"><p>&nbsp;</p> <p><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.</span></p> <p><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">Legend Biotech maintains a drug-free workplace.</span></p> <p><span style="font-family: arial, helvetica, sans-serif;">For information related to our privacy notice, please review: <a href="https://legendbiotech.eu/en/privacy/" target="_blank">Legend Biotech Privacy Notice</a>.</span></p></div>