Batch Record Reviewer II
Core
Audits Manufacturing and Packaging batch records, manages inventory system transactions to release batches, and coordinates problem-solving activities to ensure compliance and operational efficiency.
Role type
Mid-level operational quality specialist (batch record release)
Builds
Released pharmaceutical product batches compliant with regulatory standards
Domain
Pharmaceutical manufacturing and packaging
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
GMP regulations knowledge, batch record auditing, inventory system transactions, problem-solving coordination, data interpretation, regulatory compliance, process improvement, yield calculation, quality hold management
Preferred skills
5+ years in Manufacturing/Finishing/Packaging, 2+ years in Batch Record Release
Technologies
Electronic batch record systems, inventory databases
Responsibilities
Review and audit Manufacturing and Packaging batch records for accuracy and completeness; Ensure batch record errors are corrected and exception documents are approved; Release batch records in electronic systems according to global, local, customer, and regulatory requirements; Lead problem-solving activities and coordinate the implementation of identified solutions; Complete basic calculations for product yield (Manufacturing) or ensure in-process and release testing is complete (Packaging); Interface with electronic databases to interpret data pertinent for release to specific countries
Seniority
Mid-level, hands-on IC
