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Document Control Specialist

Branchburg, NJ 08876

Posted: 07/28/2023 Employment Type: Contract Job Category: Other Job Number: 578691 Is job remote?: Yes Country: United States

Job Description

Target PR Range: 18-24/hr
*Depending on experience

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%

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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