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San Diego, California, United States
Onsite
Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, 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 more than 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, Facebook and YouTube. (*in collaboration with AbbVie)
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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 appropriate
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
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 effective organizational skills
Strong verbal and written communication skills
Ability to quickly assess new information and communicate requirements to the appropriate individuals
Basic knowledge of FDA and EU regulations and ICH Guidelines and their applicability to CGMP drug substance and drug product manufacturing
Hands-on experience reviewing quality records related to GMP manufacturing (e.g., batch records, labeling, deviation reports, specifications, change controls, CAPAs)
Ability to identify and escalate problems and follow-through with corrective actions
Experience with investigation methodologies (e.g., fishbone diagrams, 5 Whys, pareto charts)
Experience with electronic quality management systems
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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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The annual base salary we reasonably expect to pay is $97,000.00-$133,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 20% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.