Documents Coordinator

Documents Coordinator responsible for auditing and assuring the accuracy of batch records to ensure compliance with policies, procedures and regulatory requirements. Key duties include determining release criteria, communicating with DQA, PR&D, and 3rd party manufacturers on document requirements; initiating Exception Reports (ERs) and Plant Information Reports (PIRs); entering and maintaining work orders, ERs, and Standard Quality Evaluations (SQEs) in the Release Batch Activity (RBA) system; using CAMBAR and AMAPS to adjust or obtain release status; auditing and maintaining records on non-batch related items (e.g., Storage Temperature Logs); coordinating isolations, holds, and reworks; reconciling product inventories with manufacturing; tracking and reporting quality statistics; training and providing work for contract workers; training new employees; ensuring holds and isolations are documented; coordinating surveillance testing and release timing of batches; preparing Certificates of Analysis; ensuring compliance with FDA/IFA regulations and other regulatory actions; roles require strong time management, organizational skills, and ability to work with cross-functional teams to meet deadlines.