Sr. Specialist, QA Operations

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 Sr. Specialist of QA Operations is responsible for providing Quality support for GMP manufacturing under general supervision.

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

• Review quality records related to GMP products manufactured by Contract Manufacturing Organizations (CMO) for compliance to CGMPs

• Perform timely disposition of GMP products in accordance with applicable regulations and internal procedures

• Participate in project teams, serving as the QA representative and escalate issues to senior QA management when appropriat

• Independently provide Quality support for new product introduction (NPI) processes for new products and/or for substantial changes to existing products (e.g., new CMO, scale-up, process validation)

• Interface with internal and external stakeholders to process quality records and resolve issues

• Lead and/or participate in deviation investigation teams

• Participate in the change control process for changes related to clinical and/or commercial products

• May participate in or conduct audits of external suppliers

• May participate in compliance inspections and inspection readiness activities

• Support and interact with other Quality functional areas to ensure compliance with internal processes and procedures and to promote continuous improvement

• Other duties as assigned

Requirements:

• BS/BA degree in Life Sciences, Engineering, or related field AND 4+ years of experience in quality within the pharmaceutical or biotechnology industry. OR

• Master’s degree in Life Sciences, Engineering, or related field AND 2+ years of similar experience as noted above

• Works well in a team environment

• Ability to work closely with both internal and external personnel

• Strong organizational and time management skills

• Ability to meet multiple deadlines with a high degree of accuracy and efficiency

• Attention to detail, critical thinker and