Batch Record Reviewer
Lonza•Tampa, FL
•Onsite
About The Position
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.
Requirements
- High school diploma or GED required
- 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.
- 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.
Nice To Haves
- Additional training or education in life sciences, quality, or related disciplines is advantageous.
- 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.
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.
Benefits
- A competitive compensation.
- 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).
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
Upload and Match Resume
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
