Documentation Specialist

Position Title : Documentation Specialist

Location : Branchburg, NJ, USA, 08876

Duration : 6 Months (Possible Extension)

Work Schedule : Monday-Friday, 7 : 30 a.m. - 4 : 00 p.m.

Work Arrangement : 100% Onsite

Position Summary :

The Documentation Specialist is responsible for creating Production Instruction (PI) sheets in the ERP system and obtaining serological test results through email, fax, and the tissue portal. This role ensures all documentation, data entry, and compliance activities are completed accurately in accordance with company procedures, FDA regulations, and AATB standards.

Key Responsibilities :

• Create and maintain PI sheets in the ERP system.
• Retrieve and manage serological test results via email, fax, and tissue portal.
• Verify and cross-reference applicable TRP paperwork and labels against ERP and RFID labels.
• Interpret test results per current procedures, applicable state and FDA regulations, and AATB standards.
• Enter serological results and final disposition decisions into the ERP system.
• Record Medical Director acceptability / deferral decisions and ensure data accuracy.
• Perform verification of serological test results and review donor charts for final grade and usage decisions.
• Assess donor charts and ERP records for completeness and grade verification.
• Track and report metrics for Medical Director deferrals and microbiological rejections.
• Collaborate with QCPR and TR teams to ensure data consistency and compliance.
• Support Tissue Services by assembling complete donor files, performing data entry, reconciling documentation, and managing ERP transactions and portal data..

Qualifications & Experience :

Skills :

Understanding of regulatory standards (FDA, AATB).