Perform complete, compliant reviews of compounding batch records to approve, reject, or hold product lots. Verify documentation, calculations, test results, deviations, CAPAs, and labeling per USP and FDA standards. Support investigations, regulatory inspections, cross-functional collaboration, mentorship of junior reviewers, and continuous improvement of batch record and quality systems.

Lead document and records control for the QMS, managing SOPs, batch and testing records, periodic reviews, filing/archival, audit retrievals, EDMS maintenance, and cross-functional training to ensure compliance with USP, GMP, and regulatory requirements.

Inspect and assess all incoming materials (APIs, excipients, packaging) for fit-for-use; review CoAs, quarantine/release decisions, document findings, manage supplier quality, improve IQA processes, and support audits and regulatory compliance.