prokidney · Winston-Salem, North Carolina, United States · Winston-Salem, North Carolina, United States
<p><span class="TextRun SCXW1959591 BCX8" lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW1959591 BCX8">Position Summary</span></span><span class="LineBreakBlob BlobObject DragDrop SCXW1959591 BCX8"><span class="SCXW1959591 BCX8"> </span><br class="SCXW1959591 BCX8"></span><span class="TextRun SCXW1959591 BCX8" lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW1959591 BCX8">The Quality Assurance Specialist I, Batch Release performs routine review and administrative activities that support material and product disposition. Working under established procedures and regular guidance, the role reviews executed manufacturing and laboratory documentation for completeness, accuracy, and compliance; records review status; </span><span class="NormalTextRun SCXW1959591 BCX8">identifies</span><span class="NormalTextRun SCXW1959591 BCX8"> discrepancies; and escalates issues to more experienced Quality personnel. This position builds foundational knowledge of cGMP requirements, data integrity, quality systems, and batch release processes.</span></span><span class="EOP Selected SCXW1959591 BCX8" data-ccp-props="{"201341983":0,"335557856":16777215,"335559740":288}"> </span></p> <p> </p> <p><span class="EOP Selected SCXW1959591 BCX8" data-ccp-props="{"201341983":0,"335557856":16777215,"335559740":288}">This is a contractor position and will not be eligible for ProKidney benefits. This position is located onsite in Winston Salem, NC and is not eligible for remote or hybrid work. This position will require flexibility and overtime as needed depending on the needs of the business. </span></p> <p> </p> <p><strong><span data-contrast="auto">Essential Duties and Responsibilities</span></strong><span data-ccp-props="{"201341983":0,"335559740":259}"> </span></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" 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 routine executed manufacturing, filling, packaging, labeling, and analytical records using approved procedures and checklists.</span><span data-ccp-props="{"201341983":0,"335559740":259}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" 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">Verify documentation for completeness, legibility, traceability, required signatures, calculations, and adherence to data integrity expectations.</span><span data-ccp-props="{"201341983":0,"335559740":259}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" 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">Identify documentation discrepancies, communicate findings, and escalate potential compliance or release-impacting issues.</span><span data-ccp-props="{"201341983":0,"335559740":259}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" 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">Compile batch disposition documentation and confirm required records are available for review.</span><span data-ccp-props="{"201341983":0,"335559740":259}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" 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">Enter and maintain accurate batch review status, deficiencies, and follow-up actions in approved GMP systems and trackers.</span><span data-ccp-props="{"201341983":0,"335559740":259}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="6" data-aria-level="1"><span data-contrast="auto">Support follow-up on missing information, corrections, and documentation responses with Manufacturing, Quality Control, and Supply Chain.</span><span data-ccp-props="{"201341983":0,"335559740":259}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="7" data-aria-level="1"><span data-contrast="auto">Assist with deviation, investigation, CAPA, change control, and controlled-document activities as assigned.</span><span data-ccp-props="{"201341983":0,"335559740":259}"> </span></li> </ul> <ul> <