Documentation Specialist II

19 hours ago

Branchburg Twp, NJ, United States US Tech Solutions Full time

Duration: 06 months contract

Job Description:

  • The Documentation Specialist II is responsible for creating, reviewing, and maintaining tissue processing documentation in accordance with FDA regulations, AATB standards, GMP requirements, and internal operating procedures. This role manages the entry and verification of serological and microbiology results in the ERP system, ensures accuracy of donor records, and supports final donor disposition review. The Documentation Specialist II collaborates with internal teams to maintain documentation integrity and assists with assembling complete donor files, performing data entry, and supporting Tissue Services operations.

Responsibilities:

  • Create PI sheets and perform documentation updates within the ERP system.

  • Retrieve serological test results via email, fax, and tissue portals, and enter results into the ERP system.

  • Verify, cross-reference, and reconcile documentation, including TRP paperwork, labels, and RFID labels, against ERP records.

  • Review and interpret serological and microbiology test results in compliance with FDA, AATB, and internal standards.

  • Enter final donor disposition, including Medical Director decisions, deferrals, and final grade verification.

  • Track metrics for Medical Director deferrals, microbiology rejections, and documentation discrepancies.

  • Assemble complete donor charts and perform thorough document reconciliation.

  • Support Tissue Services with data entry, ERP transactions, and portal management.

  • Ensure all documentation and recordkeeping meet regulatory and procedural requirements.

Experience:

  • 1–3 years of experience in a GMP environment required.

  • 1–3 years of experience in the medical, pharmaceutical, biotechnology, or tissue processing industry preferred.

  • Experience with ERP systems and documentation verification is a plus.

Skills:

  • 1-to-3-year medical/pharmaceutical industry preferred.

  • Data Entry.

  • Medical Terminology.

  • Familiarity with GMP, FDA regulations, and AATB standards.

  • Ability to interpret laboratory and serological test results.

Education:

  • High school diploma or GED required.

  • Bachelor’s degree in a scientific, healthcare, or related field preferred.

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com (http://www.ustechsolutionsinc.com) .

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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