Batch Record Reviewer

Responsibilities

• Perform detailed reviews of Batch Production Records (BPRs) to ensure accuracy, completeness, and cGMP compliance, supporting timely batch release.
• Collaborate cross-functionally with Manufacturing, Quality, QC, MSAT, and Supply Chain to resolve discrepancies and strengthen data integrity.
• Identify, document, and support resolution of deviations, driving improvements through TrackWise and related systems.
• Analyze trends in documentation errors, deviations, and performance metrics to recommend process improvements and enhance Right First Time (RFT) performance.
• Verify alignment of documentation with Master Batch Records, SOPs, and regulatory standards to maintain audit readiness.
• Develop reports and dashboards (e.g., Excel, Power BI) to monitor operational performance and support data-driven decision-making.
• Provide guidance and training to operations teams on Good Documentation Practices (GDP), data integrity, and compliance expectations.

Requirements

• High school diploma or GED required; additional training or education in life sciences, quality, or related disciplines is advantageous.
• Experience in a cGMP, pharmaceutical, or other regulated environment with exposure to batch record review and quality documentation.
• Strong attention to detail with the ability to analyze data, identify discrepancies, and ensure documentation accuracy.
• Familiarity with Quality Management Systems (QMS), including deviations, CAPA, and change control processes preferred.
• Experience with systems such as SAP, TrackWise, or similar electronic documentation platforms is highly valued.
• Proficiency in Microsoft Excel or similar tools for data analysis and reporting.
• Effective communication and collaboration skills, with the ability to work across multiple teams and influence process improvements.
• About Lonza
• Ready to shape the future of life sciences?

Benefits

Additional Information

Batch Record Reviewer Location: Tampa, FL Join our team in Tampa as a Batch Record Reviewer, where you will play a critical role in ensuring product quality and compliance in a fast-paced GMP manufacturing environment. This role offers the opportunity to make a direct impact on delivering life-saving therapies through precision, collaboration, and continuous improvement. This is a fully site‑based role. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards. What you will get: A competitive compensation. In addition, below you will find a comprehensive summary of the benefits package we offer: Performance-related bonus. Medical, dental and vision insurance. 401(k) matching plan. Life insurance, as well as short-term and long-term disability insurance. Employee assistance programs. Paid time off (PTO). Compensation for this role will be determined by the candidate's qualifications, skills, experience, and relevant knowledge.

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