Batch Record Reviewer

Lonza•Tampa, FL

1d•Onsite

About The Position

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.

Requirements

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).

Nice To Haves

Experience with QMS (deviations/CAPA/change control), ERP systems such as SAP, or electronic document management tools (e.g., TrackWise, D2).

Responsibilities

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.