Actalent
Port Washington, NY, USA
Job Title: QA Associate - Batch Record ReviewJob Description Perform detailed batch record review for manufacturing, packaging, and labeling operations to ensure accuracy, completeness, and compliance with cGMP requirements, including in a sterile manufacturing facility. Verify that all critical process steps, test results, deviations, and yields are properly documented. Identify documentation errors, inconsistencies, or missing information and coordinate corrections with Manufacturing, Quality Control, and other departments. Responsibilities Review equipment cleaning logs, line clearance forms, and related production documents. Support lot disposition activities by preparing QA documentation packets for final review. Assist in investigating deviations, nonconformances, and CAPAs as needed. Participate in internal audits and support external regulatory inspections. Maintain QA documentation according to standard operating procedures....

