Specialist, QA Systems

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:

Provides quality assurance support for electronic document management system (EDMS), quality management system (QMS), and learning management system (LMS) under general supervision. Responsible for assisting in day to day operations of the electronic systems managed by the Quality Systems Department and ensures compliance with company policies and procedures, ICH, FDA and EU requirements, cGMP, and other applicable requirements.

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

• QA Systems

• Assists with user account management and basic security settings

• Helps respond to routine eSystem customer inquiries

• Assists in generating reports and dashboards for QADC and QMS analytics

• Supports data entry and file reconciliation activities

• Assists in system documentation maintenance

• Participates in routine quality assurance activities

• Supports inspection readiness activities

• QA General

• Write SOPs for the creation, development or improvement of processes related to quality systems

• Prepare reports for management review of key statistics such as vendor performance based on findings from batch and analytical record reviews

• Assist during compliance inspections and audit readiness as required

• Other duties as assigned

Requirements:

• 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

• Familiarity with regulatory documents is required

• Developing knowledge of FDA regulations and GxP guidelines

• Understands Neurocrine's business objectives and developing understanding of Neurocrine's services and customers

• Comfortable with tools and processes that support work conducted by functional area

• Ability to work as part of a team