Documentation Specialist

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 :

Education : High school diploma required; bachelor's degree preferred.

Experience : 1-3 years in a GMP-regulated environment; medical or pharmaceutical industry experience preferred.

Skills :

SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at nahr@spectraforce.com if you require reasonable accommodation.