QC Specialist, Lab Services, II/III at Legend Biotech

<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 R&amp;D 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;">&nbsp;</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 &amp; 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;">&nbsp;</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>QC Specialist, Lab Services, II/III</strong> as part of the&nbsp;<strong>Quality </strong>team based in <strong>Raritan, NJ.&nbsp;</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 QC Specialist, Lab Services is responsible for sample management. The QC Specialist is&nbsp;encouraged to work independently on routine tasks and have conceptual understanding of all&nbsp;Quality Control functions and business areas. May need supervision/support to resolve some&nbsp;sophisticated issues. He/ She will serve as technical specialist within job function. Thinks logically&nbsp;and acts decisively.</span></p> <p class="drawer-body-p"><strong><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Shift (Alternates Weekly)&nbsp;</span></strong></p> <ul> <li class="drawer-body-p"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span data-olk-copy-source="MessageBody">Wednesday-Saturday 5:00pm-4:00am&nbsp;</span></span></li> <li class="drawer-body-p"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span data-olk-copy-source="MessageBody">Thursday-Saturday 4:00pm-4:00am</span></span></li> </ul> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong>Key Responsibilities</strong>&nbsp;&nbsp;</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;">Prepares and reviews documentation independently.<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;">Responsible for QC sample and retain management.<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;">Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify gaps in processes or systems.<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;">Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint) and lab management software system (LIMS).<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;">Prepare documents and coordinate Sample shipment (internal and external shipments).<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;">Review logbooks and/ or LIMs to align physical quantities of samples in freezers/refrigerators.<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;">Periodic inspection and consolidation of retains.<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;">Document and perform sample management related non-conformance investigations.<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;">Document and handle corrective and preventative action records.<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;">Supports internal and regulatory audits.</span></li> </ul> </div> <div class="col-xs-12 no-horiz-padding"> <h3><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Requirements</span></h3> <ul> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">A minimum of a Bachelor’s degree or higher.<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;">A minimum of two (2) years related experience in medical device, biopharmaceutical, or pharmaceutical industry.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">A degree in Biology, Biochemistry, Microbiology, Chemistry or related field.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Solid understanding of regulatory requirements, policies and guidelines.<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;">Experience with Quality Control document reviews and regulatory inspection processes.<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;">Working knowledge of Quality systems.<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;">Experience in management of retain samples using electronic systems (eLIMS).</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Candidates must be able to accommodate shift schedule. Shifts include weekend and evening work as required by the manufacturing process.<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;">This position will be located in Raritan, NJ and may require up to 5% of travel.<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;">This position will occasionally require to lift up to 20 pounds.</span></li> </ul> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">#Li-RP1</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">#Li-Onsite</span></p> <hr></div><div class="content-pay-transparency"><div class="pay-input"><div class="description"><p>The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.</p> <p>Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.</p> <p>Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&amp;D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.</p></div><div class="title">Pay Range (Base Pay): </div><div class="pay-range"><span>$83,711</span><span class="divider">&mdash;</span><span>$109,870 USD</span></div></div></div><div class="content-conclusion"><p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong>Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.</strong></span></p> <p>&nbsp;</p> <p style="line-height: 1.2;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>EEO Statement</strong></span></p> <p style="line-height: 1.2;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.</span></p> <p style="line-height: 1.2;">&nbsp;</p> <p style="line-height: 1.2;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.</span></p> <div>&nbsp;</div> <div><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">For information related to our privacy notice, please review:&nbsp;<a href="https://legendbiotech.com/privacy-notice/" target="_blank">Legend Biotech Privacy Notice</a>.</span></div></div>