Sr. Specialist, QC

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.

Neurocrine Biosciencesis 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, visitneurocrine.com, and follow the company onLinkedIn,XandFacebook. (*in collaboration with AbbVie)

About the Role:

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• Review and approve API and drug product analytical records for clinical and commercial products

• Review and approve stability data supporting retest period assignment for clinical and commercial products. May perform analytical testing to support stability studies, as needed

• Review and approve analytical test method validation protocols and reports. May perform analytical testing to support validation activities, as needed

• Review and approve equipment/instrument qualification, calibration and maintenance records to support the internal GMP lab

• Participate in project teams, serving as the QC representative and escalate issues to senior Quality management when appropriate

• Interact with cross-functional team members, external manufacturing sites and contract testing labs to resolve analytical testing issues

• Participate in deviation and laboratory investigation teams

• Review and compile data for regulatory submissions

• Conduct and support audits of external vendors

• Assist during onsite inspections and inspection readiness activities

• Perform additional duties as assigned by management

• B.S. Degree in Chemistry, Biology, or related field and 4+ years of experience within the pharmaceutical or biotechnology industry OR

• Master's and 2+ years of related experience

• Experience applying CGMP requirements in a Quality Control setting

• Working knowledge of quality systems and regulatory compliance requirements within a clinical and commercial drug manufacturing operation

• Experience in analytical development and/or testing in a Quality Control setting

• Experience with using electronic documents management systems, laboratory data management systems, document control and records management

• Knowledge of US FDA and European regulations and ICH Guidelines

• Works well in a team environment

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

• Capable of handling multiple responsibilities and prioritizing appropriately

• Attention to detail, critical thinker and effective organizational skills

• Ability to identify and escalate problems and follow-through with corrective actions

• Ability to work closely with both internal and external personnel to increase the level of compliance and cooperation while creating opportunities to improve operations and effective implementation to reduce errors

• Apply problem-solving tools for root cause analysis

• Excellent computer skills

• Strong communication skills

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Neurocrine Biosciences is an EEO/Disability/Vets employer.

We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description.

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