Documentation Specialist
TR/079998
Posted: 04/12/2025
- $25 per hour
- United States, New Jersey, Madison
- Contract
Documentation Coordinator – Medical/Pharma | $25/HR | Branchburg, NJ
6-Month Contract | Monday–Friday | 7:30 AM–4:00 PM
Join a team that helps ensure the safety and traceability of life-changing medical products!!
Orion Group is seeking a detail-driven, quality-focused Documentation Coordinator to support documentation, compliance, and data accuracy within a highly regulated medical environment. This role is ideal for someone who enjoys precision-focused work and wants to contribute to processes that directly support patient safety.
Fun Fact: The documentation you process helps ensure tissues and medical materials meet FDA and AATB standards—impacting real patients every single day.
What You Will Do
As the Documentation Coordinator, you will act as a quality gatekeeper—managing critical data, verifying compliance, and ensuring donor information is documented accurately and efficiently.
Documentation & Verification
Candidates must have:
Every document you manage directly contributes to product safety and quality. If you value accuracy, compliance, and meaningful work, this role provides the opportunity to make a measurable impact.
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
6-Month Contract | Monday–Friday | 7:30 AM–4:00 PM
Join a team that helps ensure the safety and traceability of life-changing medical products!!
Orion Group is seeking a detail-driven, quality-focused Documentation Coordinator to support documentation, compliance, and data accuracy within a highly regulated medical environment. This role is ideal for someone who enjoys precision-focused work and wants to contribute to processes that directly support patient safety.
Fun Fact: The documentation you process helps ensure tissues and medical materials meet FDA and AATB standards—impacting real patients every single day.
What You Will Do
As the Documentation Coordinator, you will act as a quality gatekeeper—managing critical data, verifying compliance, and ensuring donor information is documented accurately and efficiently.
Documentation & Verification
- Create PI sheets in the ERP system with a high level of accuracy.
- Retrieve serological test results via email, fax, and a tissue services portal.
- Verify and cross-reference TRP paperwork, labels, ERP entries, and RFID data.
- Interpret serological results in accordance with state, FDA, and AATB regulations.
- Enter and verify all results in the ERP system, ensuring documentation is complete and compliant.
- Enter final donor disposition including Medical Director decisions, microbiology findings, and serology outcomes.
- Assign donor chart grades and usage decisions based on regulatory standards and internal procedures.
- Track key metrics such as Medical Director deferrals and microbiological rejections.
- Collaborate with QCPR and TR teams on quality-related documentation.
- Assemble detailed donor files and assist with document reconciliation.
- Support ERP transactions, data entry activities, and portal updates.
- Provide general support to the team as needed to maintain smooth operations.
Candidates must have:
- 1–3 years of experience in a GMP-regulated environment
- Experience in the medical or pharmaceutical industry (preferred)
- Strong data entry skills and familiarity with medical terminology
- High attention to detail and commitment to accuracy
- Ability to work in a structured, fast-paced environment
Every document you manage directly contributes to product safety and quality. If you value accuracy, compliance, and meaningful work, this role provides the opportunity to make a measurable impact.
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
Danielle StGeorge
Recruiter
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