Batch Record Reviewer

Title: Batch Record ReviewerLocation: East Coast (Eastern Time Zone), United StatesPositions: 3Work Schedule: 100% OnsiteRole: QA Batch Record ReviewerPosition OverviewThe Sterile Manufacturing Batch Record Reviewer plays a critical role in ensuring the quality, accuracy, and compliance of sterile pharmaceutical products by conducting thorough and detailed reviews of batch records. This position requires strong attention to detail, analytical thinking, and a comprehensive understanding of current Good Manufacturing Practices (cGMP) and regulatory expectations.Key ResponsibilitiesReview batch records for sterile manufacturing processes to ensure compliance with established procedures, regulatory requirements, and industry standards.Verify the accuracy, completeness, and integrity of documentation, including production records, equipment logs, and deviation reports, ensuring alignment with approved protocols and Standard Operating Procedures (SOPs).Perform detailed, line-by-line review of batch records, confirming the consistency and accuracy of data entries, calculations, and required signatures.Identify discrepancies, deviations, or non-conformances during the review process and collaborate with manufacturing personnel to resolve issues. Provide feedback and guidance to reinforce cGMP expectations.Document findings, observations, and recommendations in formal review reports, ensuring clear and effective communication with Manufacturing and Quality Assurance teams. Utilize standardized checklists when applicable to ensure consistency.Participate in internal review meetings, presenting batch record findings and supporting discussions related to documentation and compliance.Collaborate cross-functionally with Production, Quality Control, and Regulatory Affairs teams to support timely product release and resolution of quality-related issues.Maintain current knowledge of industry trends, regulatory guidelines, and best practices related to sterile manufacturing and documentation compliance.Adhere strictly to safety protocols and cleanroom procedures to ensure product integrity and prevent contamination.QualificationsStrong knowledge of cGMP regulations and sterile manufacturing processesExcellent attention to detail and documentation review skillsStrong analytical and problem-solving capabilitiesEffective communication and cross-functional collaboration skillsExperience in batch record review within a regulated pharmaceutical environment preferredThis role is ideal for professionals seeking to contribute to high-quality sterile manufacturing operations within a highly regulated environment.