Batch Release Auditor
Core
Audits batch records for compliance with policies, procedures, and regulatory requirements to ensure accurate product release decisions.
Role type
Quality Assurance Batch Release Auditor
Builds
Batch release systems and compliance documentation
Domain
Healthcare / Pharmaceutical Manufacturing
Required skills
Batch record auditing, regulatory compliance knowledge, corrective action planning, data retrieval, system management, documentation, issue tracking, product disposition management
Preferred skills
None stated
Technologies
Batch release systems
Responsibilities
Maintain and improve batch release systems, conduct batch record audits, follow up on compliance issues, coordinate corrective action plans, generate routine reports, manage material and batch status transactions, ensure proper isolation and disposition of affected materials
Seniority
Mid-level, hands-on IC
