Neurocrine Biosciences
Specialist, QA Systems
US CA San Diego · Senior
Sponsorship not specified$77k-$105kDetected 2 days ago
GCPVendor ManagementGMPFDA RegulatoryCommunicationCollaborationProblem SolvingGxP
Stay score
odds of building a lasting career here
50Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role90
Entry-level history0
PERM / green-card track0
Lottery odds (Level II)66
Fits your clock70
Sponsors, but it's cap-subject — you still face the weighted lottery (~30% per draw at Level II). Good if you win; have a cap-exempt backup on your list.
Lottery odds assume a STEM candidate.
Personalize to your clock →Employer immigration record
from this employer's Department of Labor filings
Files H-1B transfers
6 transfer filings in the last year, covering 6 workers. Median labor-condition decision: 7 days. An employer that already files transfers is one that can take over an existing H-1B.
Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.
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About the role
- Your Contributions (include, but are not limited to):
Responsibilities
- Support the maintenance and use of electronic quality systems, including user support, system documentation, and routine system-related activities
- Edit, maintain, and process revisions of SOPs, work instructions, and other controlled documents to ensure accuracy and consistency
- Support inspection and audit readiness activities, including coordination and execution of back room and inspection room support
- Generate and maintain routine reports, metrics, trackers, and dashboards to support QA performance monitoring and data integrity
- Identify and communicate quality or compliance issues within defined processes; escalate and support follow-up actions and resolution
- Support continuous improvement initiatives by identifying opportunities and assisting with implementation within defined scope
- Collaborate with cross-functional stakeholders to support project deliverables and ensure compliance with GxP requirements and company policies
Requirements
- 6+ years of applicable experience/training OR
- 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
- Demonstrated problem-solving and analytical skills, with the ability to exercise judgment within defined procedures
- Proficiency with standard computer applications and systems
- Ability to apply company policies and procedures to resolve routine to moderately complex issues
- Knowledge of documentation practices and requirements to ensure accuracy, completeness, and traceability of QA records
Compensation
- The annual base salary we reasonably expect to pay is $76,800.00-$105,000.00.
Company info
- 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 )
- About the Role:
- Supports the execution and maintenance of quality systems and compliance processes within a GxP-regulated environment. Performs moderately complex activities with general supervision, applying established procedures and sound judgment to ensure quality systems and related processes (e.g., deviations, change control, vendor management, product complaints, document control) remain compliant with internal standards and regulatory requirements. Contributes to the effectiveness of the Quality Management System (QMS) by supporting process improvements, maintaining data integrity, and collaborating with cross-functional partners. Applies developing subject matter knowledge of GxP regulations and quality systems to resolve routine to moderately complex issues and escalate as appropriate. _
- 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 )
- Biosciences is a leading biopharmaceutical company with a simple purpose:
- to relieve suffering for people with great needs.
- Review and process controlled documents to ensure proper formatting, completeness, and compliance with company standards and procedures
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This listing is sourced directly from Neurocrine Biosciences's careers page and normalized into a canonical job model.