Specialist, QA Systems

Who We Are:
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.
_
Your Contributions (include, but are not limited to):
Perform day-to-day moderately complex activities for quality systems and processes, including document control, LMS administration, vendor-related processes, investigations, product complaints, change control, CAPA, SCAR, and deviations
Execute administrative and operational tasks, including data entry, document processing, record maintenance, and reconciliation of QA records to ensure accuracy, completeness, and traceability
Support the maintenance and use of electronic quality systems, including user support, system documentation, and routine system-related activities
Review and process controlled documents to ensure proper formatting, completeness, and compliance with company standards and procedures
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
Collaborate with cross-functional stakeholders to support project deliverables and ensure compliance with GxP requirements and company policies
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
Maintain working knowledge of applicable GxP regulations, internal procedures, and industry standards
Perform other QA-related duties, as assigned
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
Strong written and verbal communication skills, with the ability to effectively collaborate with cross-functional stakeholders
Solid organizational, planning, and prioritization skills, with the ability to manage multiple tasks in a dynamic environment
Strong attention to detail with a focus on accuracy, data integrity, and compliance
Demonstrated problem-solving and analytical skills, with the ability to exercise judgment within defined procedures
Ability to work effectively both independently and as part of a team
Proficiency with standard computer applications and systems
Ability to apply company policies and procedures to resolve routine to moderately complex issues
Working knowledge of quality systems and compliance processes within a GxP-regulated environment (e.g., deviations, CAPA, change control, document control, training, supplier quality, product complaints)
Understanding of applicable regulatory requirements and industry standards (e.g., FDA, ICH, GxP, GMP, GLP, GCP)
Experience supporting electronic quality systems (e.g., QMS, LMS) including data entry, record maintenance, and basic system support
Knowledge of documentation practices and requirements to ensure accuracy, completeness, and traceability of QA records
Familiarity with audit and inspection support activities, including document retrieval and tracking
Ability to generate and interpret standard QA reports, metrics, and dashboards to support monitoring and review
#LI-RS1
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.
_
The annual base salary we reasonably expect to pay is $76,800.00-$105,000.00. 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.