Specialist, QA Systems – Training

Who We Are:

At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs.

What We Do:

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, 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 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 and Facebook. (*in collaboration with AbbVie)

About the Role:

The QA Systems Specialist will perform day-to-day QA and GXP learning activities and duties. This will include administration of the Learning Management System (LMS), collaboration with process and document owners for training courses, coordination and management of annual GXP training requirements, authoring, align, and manage the GXP training curricula matrix, troubleshooting electronic document learning management issues, assists with management of competency assessments, as applicable, and performance and administration of training courses (classroom and electronic).

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Your Contributions (include, but are not limited to):

• Assist in maintaining training matrix and curricula in alignment with business structure;

• Collaborate with document owners and functional area heads to define requirements for controlled document and GXP training courses;

• Perform new hire orientation and training on the LMS, GXP, eSignature, etc.;

• Assist in validation activities for LMS change controls and releases;

• Assist with development of competency assessments for training events and controlled documents, as applicable;

• Manage periodic review of training curricula and training materials;

• Collaborate in the creation and review of applicable controlled documents;

• Administer and perform QA training events for EDMS and QMS user community;

• Responsible for GXP training metrics for monthly and quarterly reports;

• Coordinate and schedule GXP training events for NBI personnel;

• Participate in and assist with inspection readiness activities;

• Perform data-entry, and reconcile legacy and active training files;

• Assist in the creation, distribution, and maintenance of training courses in the LMS;

• Support the development, implementation, and maintenance of GXP training materials and program(s);

• Participate in or lead meetings and projects with cross-functional LMS Core team;

• Perform quality