Batch Record Reviewer

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.

What you will do:

• 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.

What we are looking for:

• 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

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Ready to shape the future of life sciences? Apply now.