Batch Record Reviewer

Batch Record Reviewer Tampa, FL Job Details Full-time 22 hours ago Benefits Health insurance Dental insurance Vision insurance Qualifications Quality control corrective actions Document review (document control) Microsoft Excel Microsoft Outlook Pharmaceutical regulatory compliance Corrective and preventive actions (CAPA) Mid-level High school diploma or GED Manufacturing standard operating procedures Analysis skills Quality control documentation Continuous improvement Batch records Pharmaceutical plant experience Quality assurance within manufacturing SAP ERP Document management systems 2 years Communication skills Supply chain collaboration Full Job Description Job Title Batch Record Reviewer Location Tampa, FL Join a highly collaborative and fast‑paced biopharmaceutical environment where you will ensure the accuracy and compliance of critical manufacturing documentation that supports timely product release and helps deliver high‑quality therapies to patients worldwide. What you will get An agile career within a dynamic and innovative Quality organization. An inclusive and ethical workplace built on collaboration and integrity. Compensation programs designed to reward high performance. Comprehensive medical, dental, and vision insurance. What you will do Review executed Batch Production Records to ensure accuracy, completeness, and adherence to cGMP and regulatory standards. Verify documentation against master records, SOPs, and specifications, escalating discrepancies or deviations as needed. Confirm critical process parameters, in‑process controls, and analytical results meet approved requirements. Partner with Manufacturing, QC, QA, MSAT, and Supply Chain to resolve documentation gaps and support timely batch disposition. Review supporting documentation such as raw material records, equipment logs, calibration data, and environmental monitoring results. Track batch record review progress and corrections to maintain alignment with production schedules. Support continuous improvement initiatives and provide guidance on Good Documentation Practices and data integrity expectations. What we are looking for High school diploma required . 2+ years of experience in pharmaceutical manufacturing, Quality Assurance, documentation review, or another cGMP‑regulated environment. Strong understanding of cGMP, regulatory guidelines, and data integrity principles. Demonstrated ability to review batch records and supporting documentation with excellent attention to detail. Strong analytical, organizational, and communication skills with the ability to clearly articulate findings. Ability to work independently in a fast‑paced, production‑driven setting. Proficiency in Microsoft Office applications (Excel, Word, PowerPoint, Outlook).

Preferred:

Experience with QMS (deviations/CAPA/change control), ERP systems such as SAP, or electronic document management tools (e.g., TrackWise, D2). 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. Ready to shape the future of life sciences? Apply now.