Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionSummary:Responsible for receiving, filing, controlling, and retrieving of executed GMP documents such as batch records and validation reports, including off-site storage. Maintains the controlled document library (archives), this includes routine filing. Manage the process for disposition of GMP documents, including shipment of documents to Clients or destruction of Client and Site documents. Support Compliance Auditors in audit preparations including document retrieval and assembly. Compliance projects as required.Essential Functions:Accurately maintain document database and archives.Retrieve documents in a timely manner.Enforce procedures governing document management and compliance requirements including records retention policies. Must collaborate cross-functionally to reinforce site requirements.Responsible for the maintaining access to the controlled Document Library including the removal and return of records stored within. Includes offsite storage of documents.Support onsite Customer and Regulatory audits.Receive, file, and retrieve documents.Manage process for disposition of GMP documents that have reached their retention periods, including shipment of documents to Clients or destruction of Client and Site documents.Prepare documentation for offsite storage.Secure required documentation on time to maintain client deadlines. Work with other departments to locate documents.Respond to regulatory, customer or internal requests for document information and to general questions pertaining to document control.Facilitate periodic review (reconciliation) of controlled documents in accordance with site procedure.Maintain a safe working environment and report potential hazards.
Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionSummary:Responsible for receiving, filing, controlling, and retrieving of executed GMP documents such as batch records and validation reports, including off-site storage. Maintains the controlled document library (archives), this includes routine filing. Manage the process for disposition of GMP documents, including shipment of documents to Clients or destruction of Client and Site documents. Support Compliance Auditors in audit preparations including document retrieval and assembly. Compliance projects as required.Essential Functions:
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