Specialist, QA Systems

Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit  neurocrine.com , and follow the company on  LinkedIn ,  X , Facebook and YouTube . ( *in collaboration with AbbVie ) About the Role: Supports the execution and maintenance of quality systems and compliance processes within a GxP-regulated environment. Performs moderately complex activities with general supervision, applying established procedures and sound judgment to ensure quality systems and related processes (e.g., deviations, change control, vendor management, product complaints, document control) remain compliant with internal standards and regulatory requirements. Contributes to the effectiveness of the Quality Management System (QMS) by supporting process improvements, maintaining data integrity, and collaborating with cross-functional partners. Applies developing subject matter knowledge of GxP regulations and quality systems to resolve routine to moderately complex issues and escalate as appropriate. _ Your Contributions (include, but are not limited to): Perform day-to-day moderately complex activities for quality systems and processes, including document control, LMS administration, vendor-related processes, investigations, product complaints, change control, CAPA, SCAR, and deviations Execute administrative and operational tasks, including data entry, document processing, record maintenance, and reconciliation of QA records to ensure accuracy, completeness, and traceability Support the maintenance and use of electronic quality systems, including user support, system documentation, and routine system-related activities Review and process controlled documents to ensure proper formatting, completeness, and compliance with company standards and procedures Edit, maintain, and process revisions of SOPs, work instructions, and other controlled documents to ensure accuracy and consistency Support inspection and audit readiness activities, including coordination and execution of back room and inspection room support Generate and maintain routine reports, metrics, trackers, and dashboards to support QA performance monitoring and data integrity Collaborate with cross-functional stakeholders to support project deliverables and ensure compliance with GxP requirements and company policies Identify and communicate quality or compliance issues within defined processes; escalate and support follow-up actions and resolution Support continuous improvement initiatives by identifying opportunities and assisting with implementation within defined scope Maintain working knowledge of applicable GxP regulations, internal procedures, and industry standards Perform other QA-related duties, as assigned Requirements: 6+ years of applicable experience/training OR BS/BA degree in Chemistry, Biology, or related field AND 2+ years of relevant experience OR Master’s degree in Chemistry, Biology, or related field AND some similar experience as noted above Strong written and verbal communication skills, with