QA Shop Floor Specialist II/III 2nd Shift

<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><hr> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Legend Biotech is seeking a <strong>QA Shop Floor Specialist </strong>as part of the <strong>Quality Operations </strong>team based in <strong>Raritan, New Jersey. </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-size: 12pt;">The QA Shop Floor Specialist is an exempt level position responsible for the floor quality oversight of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations.</span></p> <p class="drawer-body-p"><span style="font-size: 12pt;">Schedule: Wed-Sat, 2^nd Shift OR Sun-Wed 2nd Shift</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-size: 12pt;">Provide Quality oversight of all aspects of the cell therapy clinical manufacturing process.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-size: 12pt;">Support manufacturing activities for cGMP compliance through spot checks/internal audits.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-size: 12pt;">Collaborate with site personnel to provide guidance and determine immediate path forward for manufacturing quality issues.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-size: 12pt;">Review of all documentation, in accordance with Good Documentation Practices (GDP).</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-size: 12pt;">Review, revise, or draft Standard Operating Procedures (SOPs)</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-size: 12pt;">Support processes that include aseptic process simulations, Commercial clinical manufacturing, miscellaneous runs that are conducted to support manufacturing to ensure sterility of the product/process is not compromised.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-size: 12pt;">Support batch review material release in SAP for In-house reagents.</span></li> <li style="font-family: arial, helvetica, sans-serif; fon ... (truncated, view full listing at source)