TEMP - 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)

Responsible for oversight of GMP analytical testing performed by contract sites and supporting internal GMP analytical laboratory operations.

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• Review and assess analytical records for clinical and commercial products in a timely manner

• Review and compile stability data for regulatory submissions

• Review and approve analytical test method validation protocols and reports for compliance and data integrity

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

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

• Take immediate action when aware of significant quality, compliance, supply and safety risks, often requiring the coordination of activity across organizational units

• Participate in deviation and laboratory investigation teams. Ensure that deviations and out-of-specification results are investigated and documented

• Perform review of procedural and method revisions, where necessary

• Participate in or conduct audits of external vendors

• Support internal audits

• Assist during compliance inspections and inspection readiness as required

• Perform additional duties as assigned by management

• B.S. Degree in Chemistry, Biology, or related field and 3+ years of experience within the pharmaceutical or biotechnology industry

• A strong understanding of CGMPs is required

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

• Experience with quality systems in analytical analyses for the biologics industry is strongly desired

• Experience with electronic document management systems is desired

• Focuses on the accurate and efficient handling of data, particularly in the context of ensuring the integrity and reliability of data used in stability testing and analysis, often within a pharmaceutical or biotechnology environment

• Accurately input and verify data from various sources, including lab results, test data, and reports, into the company's database or LIMS

• Experience with H&A SLIM and SLIMStat

• Support sample inventory, including labeling, organizing, and placing samples in stability chambers at appropriate intervals

• Update and maintain LIMS systems, ensuring accurate and up-to-date information regarding protocol and sample activities

• Review data for errors and inconsistencies, and provide data and graphical summaries to support investigations

• Experience with Veeva, Smartsheets, Microsoft Office

• Works well in a team environment with the ability to drive results

• 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 required

• 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

• Analytical skills for data verification and error detection

• Organizational skills for managing large datasets and records

• Communication skills for collaboration and reporting

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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.