Document Coordinator I

Our Work MattersAt Kindeva we make products that save lives ensuring better health and well-being for patients around the KindevaPurpose-driven work environmentSignificant growth opportunitiesCollaborative team-oriented cultureDirect impact on patient careIndustry-leading pharmaceutical innovationROLE SUMMARYThe document control coordinator is responsible for coordinating the system by which changes are made to controlled GMP documents such as SOPs Forms Batch Records printed material specifications device design documents (DHF documents) etc. This includes issuing production batch records as well as maintaining several Tracking databases; formatting various document types to conform to approved templates within the Quality Document Management System (QDMS); finalizing approved GMP documents and ensuring copies are distributed to contract customers and Regulatory Affairs as needed. Responsible for preparation and maintenance of master GMP RESPONSIBILITIESEssential responsibilities include:Controlled document management: Create format revise issue reconcile archive and maintain GMP-controlled documents and logbooks in accordance with applicable procedures. Document types include SOPs master batch records specifications laboratory methods protocols Design History File documents training materials reference manuals job aids and compliance: Administer GMP documentation within the Quality Document Management Systems (QDMS) including document properties formatting change summaries reviewer assignments and approval routing to support compliance with applicable procedures policies regulations and quality record support: Issue and reconcile laboratory production replacement redlined supermarket media fill machine trial experimental and research batch records in accordance with production schedules and approved retention and archiving: Maintain company records within the record retention program. Scan upload and archive batch records sterilization records raw material test reports cleanability assessments and related records in the applicable electronic archive shared file or archival system in accordance with site SOPs and retention and transfer support: Create and maintain QA Documentation tracking databases and prepare site transfer cases as and project support: Serve as document author and subject matter expert for document management processes support department projects and perform assigned QA Documentation coverage: Support occasional late-night or weekend work based on business duties as QUALIFICATIONSMinimumAssociates degree in a science fieldPreferred:Experiencein a GMP environment preferably within Quality.#LI-Onsite