Quality Assurance Records Management Analyst, 1st Shift Position Available In Middlesex, New Jersey

Overview/Risks MTF Biologics processes tissue grafts from human donors that are used in a growing array of clinical applications – positively affecting lives across the globe. As a global nonprofit organization that saves and heals lives by honoring donated gifts and serving patients, we collaborate with the medical, scientific, as well as organ and tissue donation communities. Our goal is simple-do what’s right for patients, surgeons, tissue donors, and their families through our guiding principles. The Quality Assurance Records Management Analyst is responsible for preparing organizing and updating IFG, 1st Review and 2nd Review and final review charts for the Quality Assurance Analysts. This includes maintaining sufficient queues of charts for review, printing results and entering data into databases. The Records Management Analyst will be responsible for reviewing documentation for the release of in process finished goods according to MTF procedures and in compliance with applicable regulatory requirements. Monday-Friday 8:15am-4:30pm Responsibilities Maintains the operational attributes & process, confidentiality, effectiveness, efficiency and security of the donor processing records and the records area Prints and analyzes results from internal and external laboratory databases, Sceris and other programs / systems, as required Proactively tracks lab results from internal and external laboratories and follows up with the lab as needed to ensure results are received in a timely manner. Communicates / escalates any issues which cannot be resolved through the normal channels Enters lab test results into databases including QDDS, Access and Excel spreadsheets Prepares charts with the appropriate paperwork and results for IFG, 1st Review and 2nd Review and Final Review Prepares (and may be required to present) performance metrics for the file room Reviews and analyzes processing batch records to ensure the release criteria is acceptable in accordance with current finished good (FG) specifications, in-process finished goods (IFG) specifications, MTF procedures for tissue and medical devices, and applicable regulatory requirements Identify deviations, discrepancies, or non-conformances associated with the work order. Notify the appropriate individuals, complete the necessary documentation, and ensure the deviations, discrepancies, or non­conformances have been resolved before the tissue or medical device units are released Completes appropriate documentation for the rejection of tissue and medical devices when required Reviews tissue and medical device processing and storage documentation Interacts with all departments to organize, review, and analyze all data pertaining to the release of tissue or medical devices for compliance with current MTF procedures, specifications and regulatory requirements Supports the Quality Analysts and all the Business Units with their queries on records Tracks processing records in and out of the file room using file tracking system or QAD Responsible for identifying, tracking and retrieving any mislaid charts Prepares, coordinates, arranges and reconciles shipments of documents required to send for off site storage QA Contact for any required retrieval from the off site storage facility Assists on special projects and performs other duties, as required Qualifications 1 year in a GMP or FDA regulated industry 2 years document review or laboratory testing Strong written and verbal communication skills Must be proficient in data entry, Microsoft Outlook, Word, and Excel Must exhibit attention to detail, critical thinking, and problem-solving and effective communication