Sr. Specialist, QA Systems
Neurocrine Biosciences · San Diego, CA
QualityFull-time$97k–$133kCompany career page
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Role summary
Neurocrine Biosciences seeks a Senior Specialist for QA Systems to execute and enhance quality systems and compliance activities in a GxP-regulated environment. The role involves managing complex quality processes, supporting continuous improvement of the Quality Management System, and serving as a subject matter resource across functional areas.
What they're looking for
- Bachelor's degree in relevant field with 4+ years pharma/biotech QA experience, or Master's degree with 2+ years experience
- Strong verbal and written communication skills with ability to engage cross-functional stakeholders
- Advanced proficiency with standard computer applications and electronic quality systems
- Deep knowledge of GxP-regulated quality systems: deviations, CAPA, change control, document control, supplier quality
- Understanding of FDA, ICH, GxP, GMP, GLP, and GCP regulatory requirements and industry standards
- Demonstrated leadership and mentorship abilities with problem-solving and analytical skills
- Experience supporting audits, inspections, and implementing process improvements; strong attention to detail
What you'll be doing
- Independently perform and coordinate complex quality systems activities including document control, vendor management, investigations, and change control
- Ensure accuracy and traceability of QA records through data entry oversight, document processing, and reconciliation
- Support electronic quality systems through user support, system documentation, and process improvement implementation
- Generate, analyze, and interpret quality reports, metrics, and dashboards to support performance monitoring and management review
- Lead discrete process improvement efforts and provide guidance and mentorship to less experienced team members
Privacy & handoff
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