Overview The position will provide assistance with maintaining GMP documentation system, implementing information systems for managing document tracking, controlled document distribution (issuance) and records management. Follow all applicable SOPs, policies and other guiding documents that describe document lifecycle management. Coordinates quality assurance program associated to creation and maintenance of GMP documents to ensure consistency with established standards. Assist with the day-to-day filing and managing the controlled documents and serves as site facilitator for records retention, archiving, destruction, and retrieval. Oversee the issuance and maintenance of logbooks. Consult with other QA and site personnel to ensure timely issuance and execution of records in the quality systems. Maintain accurate records for the location of records generated by quality systems. Identifies areas of improvement in the documentation system and assist in administering the change control system (issuance, tracking, and implementation). To handle the company’s document management needs. Store, track and manage the company’s documents, both in electronic and paper formats. Must be accurate, and keep the information safe and confidential. Assist with preparing reports and presentations. Key Accountabilities: - Maintain and manage filing system for GMP related documents which includes batch records, specification/Quality Assurance Reports and other documents. - Facilitate and coordinate in posting approved SOPs, Test Methods, Master Batch Records (MBRs) and GMP records for training and subsequent effectivity. - Handling the distribution of those documents. - Assist with issuance of MBPs - Be in charge of writing annual product reviews - Maintains order in the documentation room; be responsible for organizing all files including the old ones for proper storage. - Maintain document database (physical and electronic; obsolete and current SOPs), revisions accurate and up-to-date - Maintain a tracking system for document routing, check-outs, etc. - Be responsible for reproducing needed documents for all staff. - Proofread the papers before distributing it. - Code and label all files for easy monitoring and tracing of documents - Archive documentation as necessary; manages the security keeping of physical/electronic files of controlled documents. Other Accountabilities: - Write and revise SOPs following company’s document change procedure - Review and improve quality system documentation; write and/or review Quality Assurance (QA) standard operating procedures to assess cGMP compliance on issues relating to sterile biologics manufacturing - Confer with document originators to understand document control needs - Types SOPs and MBRs submitted by requester from draft to final form, as needed.