Overview
Data Entry Clerk Jobs in Somerville, NJ at Collabera
Title: Data Entry Clerk
Company: Collabera
Location: Somerville, NJ
The Documentation Coordinator is responsible for ensuring accurate data entry, verification, and management of documentation in compliance with GMP industry standards, FDA regulations, and AATB guidelines. This role focuses on the creation, interpretation, and verification of serological test results and donor chart documentation within the ERP system.
Key Responsibilities:
Documentation Management:
Create Product Information (PI) sheets in the ERP system.
Obtain serological test results via email, fax, and the tissue portal.
Verify and cross-reference applicable paperwork and labels against the ERP system and RFID labels.
Enter serological test results and final dispositions into the ERP system, ensuring accuracy and compliance.
Compliance and Verification:
Interpret test results in alignment with procedures, FDA regulations, and AATB standards.
Perform verification of serological results and ensure all documentation is clear, concise, and audit-ready.
Assess donor charts for final grade verification and usage decisions based on consent, Medical Director decisions, and serological reviews.
Metrics and Reporting:
Track and report metrics for Medical Director deferrals and microbiological rejections.
Collaborate with QCPR and Tissue Review (TR) teams to ensure accurate documentation.
Team Support:
Assist the Tissue Services department with donor file assembly, data entry, ERP transactions, document reconciliation, and portal management.
Provide additional support as deemed necessary by the team.
Qualifications:
Education:
High school diploma required; Bachelor’s degree preferred.
Experience:
1 to 3 years of work experience in a GMP-regulated environment.
1 to 3 years of experience in the medical or pharmaceutical industry preferred.
Skills:
Proficiency in data entry and ERP systems.
Familiarity with medical terminology.
Strong attention to detail and ability to interpret complex documentation.
Excellent organizational and communication skills.
