Quality Specialist III, Batch Record Review
Core
Reviewing batch records and supporting product release for sterile and oral solid dose pharmaceutical manufacturing to ensure compliance with GMP and regulatory requirements.
Role type
Quality Assurance Specialist (Batch Release)
Builds
Pharmaceutical products (sterile and oral solid dose)
Domain
Pharmaceutical manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP/GxP regulations knowledge, batch record review, product disposition, deviation management, CAPA, change control, root cause analysis, quality systems proficiency
Preferred skills
None stated
Technologies
TrackWise, Microsoft Office
Responsibilities
Perform comprehensive batch record review, ensure documentation completeness, collaborate on batch-related issues, evaluate deviations and change controls, support inspection readiness, contribute to continuous improvement
Seniority
Mid-level, hands-on IC