QA Document Control Specialist I/II/III

<div class="content-intro"><p style="line-height: 1.2;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three RD sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.</span></p> <p style="line-height: 1.2;"> </p> <p style="line-height: 1.2;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.</span></p> <p style="line-height: 1.2;"> </p></div><div class="col-xs-12 no-horiz-padding"><hr> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Legend Biotech is seeking <strong>QA Document Control Specialist I/II/III</strong> as part of the <strong>Quality </strong>team based in <strong>Raritan, NJ. </strong></span></p> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong>Role Overview</strong></span></p> <p class="drawer-body-p"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">The QA Document Control Specialist role is an exempt level 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> <p class="drawer-body-p"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Schedule: <span data-teams="true">2nd Shift, Wed-Sat, 2 PM - 12:30 AM</span></span></p> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong>Key Responsibilities</strong> </span></p> <ul> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">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-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Support Document Management system users with workflow handling and electronic system usage<br></span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Manage the periodic review process for procedures<br></span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Issuance of batch related documentation in support of GMP manufacturing<br></span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Reconcile GMP documentation following document lifecycle requirements<br></span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Creation and issuance of GMP logbooks<br></span></li> <li style="font-family: arial, ... (truncated, view full listing at source)