Job Description

Description:

The Batch Record Reviewer I is responsible for the accurate and timely review of batch records to ensure compliance with cGMP, internal quality standards, and regulatory requirements. This role involves verifying data entries, calculations, and documentation for completeness and accuracy, identifying and resolving discrepancies, and ensuring that all deviations, investigations, and change controls are properly documented and addressed. The reviewer works closely with Production, Quality Assurance, and other cross-functional teams to support product release, maintain data integrity, and uphold product quality and patient safety.

Essential Functions:

• Perform final review of manufacturing documentation for completeness and compliance with cGMP, SOPs, and regulatory requirements before release.
• Deliver requested lot status updates to support production and quality activities.
• Ensure that deviations, discrepancies, and non-conformances are properly documented and escalated for investigation.
• Document and report identified documentation errors to management, ensuring proper tracking for trend analysis and use in training and continuous improvement initiatives
• Support compliance and quality initiatives by partnering with QA–Manufacturing, Compliance, and Investigation groups during real-time reviews, and providing record retrieval and filing assistance across departments.
• Provide support during internal/external audits, as requested.

Additional Responsibilities:

• Perform additional duties as requested.
• Participate in and support continuous improvement activities, maintain a clean and organized work space area to ensure compliance.
• Release of production rooms, along with in-process checks and review/audit of E-log books
• Entry of engineering work orders, including coordination and tracking of preventive maintenance activities
• Performing operator-level job responsibilities in production areas as part of cross-functional activities, if needed