Job Description:
Under general direction, this position will ensure accurate entry of information from Tissue Transplant Return Cards (TTR) and Data Registry Cards. Working with other departmental personnel, the document coordinator will maintain and file records, as well as maintain the file room. This position will prepare, process, and sustain storage of in-house and offsite records, as well as the support of the creation of electronic files of records. The Documentation Coordinator will interact with other departments, including Production, Tissue Service, Post-Market Quality Assurance, and Quality Control, to complete the process of reviewing, logging, and filing documents.
· Ensure accurate entry of the Tissue Transplant Return Card (TTR) and Data Registry Card data into the SAP system. This includes medical information. 70%
· May be required to enter, query and/or data fix/troubleshoot. 5%
· File and maintain records and documents. Organize paperwork and electronic records for filing; maintain an efficient file room and network system. 5%
· Produce digital copies (scans) of paper documents/records. Electronic copies documents/records need to be legible and organized on company network and/or other storage devices. 5%
· Follow retention process for offsite storage records. Prepare records for transportation to\from offsite facility by collecting vital record information, completing forms, packing boxes and creating an electronic record for future reference. 5%
· Thoroughly carry out all relevant training in compliance with procedures, standards, regulations, and other governed bodies. 5%
· Assist in internal & external audits. Maintain understanding of current regulations & guidelines related to document & change control, such as FDA Good Manufacturing Practices, FDA Good Tissue Practices, AATB Good Tissue Practices, state regulations,
ISO 9001, ISO 13485, ISO 14971 standards, local site policies/procedures, 93/42 EEC Medical Device Directive, and other applicable standards. 5%
