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    "requisitionDescription": "<div><div><div><div><div><link href=\"https://static.workforcenow.adp.com/mas/mdf-components/23.32.33/styles/froala_editor.pkgd.min.css\" rel=\"stylesheet\" type=\"text/css\">&nbsp;<link href=\"https://static.workforcenow.adp.com/mas/mdf-components/23.32.33/styles/froala_style.min.css\" rel=\"stylesheet\" type=\"text/css\"><div class=\"fr-view\"><p id=\"isPasted\"><strong>Sagent Pharmaceuticals - Schaumburg, IL</strong></p><p><strong>Quality Specialist, Batch Release&nbsp;</strong></p><p><strong><em style='box-sizing: border-box; outline: none; --tw-shadow: 0 0 #0000; --tw-ring-inset: ; --tw-ring-offset-width: 0px; --tw-ring-offset-color: #fff; --tw-ring-color: rgba(59,130,246,.5); --tw-ring-offset-shadow: 0 0 #0000; --tw-ring-shadow: 0 0 #0000; color: rgb(38, 35, 33); font-family: Circular, -apple-system, BlinkMacSystemFont, \"Segoe UI\", Roboto, Oxygen, Ubuntu, Cantarell, \"Fira Sans\", \"Droid Sans\", \"Helvetica Neue\", sans-serif; font-size: 16px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; background-color: rgb(255, 255, 255); text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;' data-pasted=\"true\">This is currently a hybrid role that requires at least 3 days per week in the Schaumburg, IL corporate office.</em></strong></p><p>Sagent Pharmaceuticals, founded in 2006, was built to focus on customer needs. &nbsp;At Sagent, we believe that excellence is our standard, our motivation and our guide. We believe the measure of success is determined by our customers, as we are a customer-focused company, delivering an extensive portfolio of injectable products and fulfilling the evolving needs of the patients we serve through our unique network of global resources.&nbsp;</p><p>We are seeking a Quality Specialist that will be responsible for the execution of batch record reviews and associated product quality issue resolution. &nbsp;Authorizes shipments from contract manufacturing organizations (CMO) once all applicable documentation has been reviewed and deemed acceptable. &nbsp;Provide direct support and guidance to new product launch initiatives and supply chain concerns. &nbsp;Ensure standards and requirements are met for all executed activities. &nbsp;Support the existing quality systems, including executing SOPs and data management activities in association with the company&rsquo;s management review process. &nbsp;Can interface with the company&rsquo;s partners to clarify, assess, and/or approve product quality concerns.</p><p><strong>This person will be expected to:</strong></p><ul><li>Review and approve batch records related to cGMP documentation- deviation and investigation reports, QC data, CoA, CoC, product labeling and specification sheets, and all documentation supporting shipment of products prior to shipment, including temperature profiling data. &nbsp;Provide guidance and support in all aspects of cGMP to our CMOs including in particular good documentation practices and root cause analysis during investigations.</li><li>Ensure all applicable data is accurate, up to date, and defendable to regulatory authority.</li><li>Provide ongoing support to the existing Quality Management System and training programs.</li><li>Write, review, or implement new standard operating procedures and policies, as necessary.</li><li>Participate on Global Alliance Management project teams to communicate quality concerns and team progress.</li></ul><p><strong>Candidate Qualifications:</strong></p><ul><li>Bachelor&rsquo;s degree in Scientific related field&nbsp;</li><li>2+ years of previous experience in a Quality related position and knowledge of GMP, GLP and FDA trends&nbsp;</li><li>2+ years of hands-on experience with Chemistry instrumentation including HPLC&nbsp;</li><li>TrackWise software experience preferred&nbsp;</li><li>Must have excellent organizational and project management skills to coordinate multiple projects</li><li>Strong&nbsp;interpersonal communication skills required &ndash; verbal, written and presentation</li></ul><p>&nbsp;</p><p><em>Sagent Pharmaceuticals is an EEO/AA&nbsp;</em><em>employer and does not discriminate on the basis of race, color, religion, sex, age, creed, national origin, veteran status, physical or mental disability and sexual orientation.</em></p></div></div></div></div></div></div>\n",
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