prokidney · Winston-Salem, North Carolina, United States · Winston-Salem, North Carolina, United States
<p><span class="TextRun SCXW69307901 BCX8" lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW69307901 BCX8">The Quality Assurance </span><span class="NormalTextRun SCXW69307901 BCX8">Specialist II, Batch Release (contractor) supports</span><span class="NormalTextRun SCXW69307901 BCX8"> Quality Operations </span><span class="NormalTextRun SCXW69307901 BCX8">by conducting detailed</span><span class="NormalTextRun SCXW69307901 BCX8"> reviews </span><span class="NormalTextRun SCXW69307901 BCX8">of executed manufacturing, packaging, labeling,</span><span class="NormalTextRun SCXW69307901 BCX8"> and laboratory </span><span class="NormalTextRun SCXW69307901 BCX8">records used in material and product disposition. The role verifies that documentation is complete, </span><span class="NormalTextRun SCXW69307901 BCX8">accurate</span><span class="NormalTextRun SCXW69307901 BCX8">, traceable, and compliant with approved procedures, specifications, data integrity requirements, and current Good Manufacturing Practice (cGMP) requirements. The Specialist partners with Manufacturing, Quality Control, Supply Chain, and other functions to resolve documentation issues, assess quality events, and ensure release decisions are supported by complete and compliant records.</span></span><span class="EOP SCXW69307901 BCX8" data-ccp-props="{"201341983":0,"335557856":16777215,"335559739":0,"335559740":288}"> </span></p> <p> </p> <p></p> <div>This is a contractor position located onsite in Winston-Salem, NC. This role is not eligible for ProKidney benefits or remote/hybrid work. Schedule flexibility, including overtime, may be required based on business needs.</div> <p><strong><span data-contrast="auto">Essential Duties and Responsibilities</span></strong><span data-ccp-props="{}"> </span></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">Review executed manufacturing, filling, packaging, labeling, and analytical records for completeness, accuracy, traceability, data integrity, and compliance with approved procedures, specifications, acceptance criteria, and applicable regulatory requirements; identify discrepancies and coordinate their resolution before disposition.</span><span data-ccp-props="{}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="auto">Compile and perform initial quality review of batch disposition documentation, confirm that required manufacturing and testing records are complete, and verify that applicable deviations, investigations, and other quality events are assessed or resolved in accordance with approved procedures before recommending the batch for final disposition.</span><span data-ccp-props="{}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="auto">Maintain accurate and timely records in departmental GMP databases and tracking systems, including data entry, follow-up, and status updates.</span><span data-ccp-props="{}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="auto">Monitor production and non-production activities for compliance with cGMP requirements and promptly document and escalate observed issues.</span><span data-ccp-props="{}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="5" data-aria-level="1"><span data-contrast="auto">Support deviation investigations, root cause analysis, corrective and preventive actions (CAPAs), and effectiveness activities; evaluate and document the</span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="12" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">Review executed manufacturing, filling, packaging, labeling, and analytical records for completeness, accuracy, traceability, data integrity, and compliance with approved procedures, specifications, acceptance criteria, and applicable regulatory requirements; identify discrepancies and coordinate their resolution before disposition.</span><span data-ccp-props="{}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="12" data