Documentation Specialist II
Location: Branchburg, NJ
Schedule: Monday–Friday, 7:30 AM – 4:00 PM (100% Onsite)
Pay: $26–$28/hour (based on experience)
Overtime: As needed
Position Overview
The Documentation Specialist supports the Tissue Services department by ensuring accurate documentation, data entry, and verification of serological, microbiological, and donor-related information within the ERP system (SAP). This role is responsible for interpreting and validating results in accordance with company procedures, state regulations, FDA guidelines, and AATB standards. The Specialist also assists with donor chart assembly, final disposition entry, and cross-functional collaboration with Medical Directors, QCPR, and TR teams.
Key Responsibilities
ERP & Data Management
- Create PI sheets and complete ERP transactions within SAP.
- Obtain serological test results via email, fax, and tissue/medical portals.
- Enter and verify serological and microbiology results in the ERP system.
- Cross-reference TRP paperwork and labels with ERP and RFID labels for accuracy.
Documentation & Compliance
- Interpret test results in alignment with procedures, state laws, FDA regulations, and AATB standards.
- Enter final donor disposition based on Medical Director decisions, consent information, deferrals, and laboratory results.
- Assess donor charts for final grade and usage decisions and ensure full documentation compliance.
- Support assembly and reconciliation of complete donor files.
Cross-Functional Support
- Track metrics related to Medical Director deferrals and microbiological rejections.
- Collaborate with QCPR and TR teams on documentation and review processes.
- Provide general support across the Tissue Services department as needed.
Required Qualifications
- High school diploma or equivalent (Bachelor’s degree preferred).
- 1–3 years of experience in a cGMP environment.
- Experience in the medical or pharmaceutical industry.
- Strong data entry skills with high accuracy.
- Basic medical terminology knowledge.
- Ability to interpret documentation in compliance-driven environments.
Preferred Skills
- Experience using ERP systems, especially SAP.
- Prior work involving serology, microbiology, donor records, or regulated documentation.
- Familiarity with AATB standards, FDA requirements, or tissue services workflows