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
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
