Regulatory Coordinator

Contract: Branchburg , New Jersey, US

Salary Range: 25.00 - 27.00 | Per Hour

Job Code: 357365

End Date: 2025-02-07

Days Left: 1 days, 3 hours left

Job Description:
Position Summary:
The Documentation Coordinator plays a critical role in the Tissue Services department, ensuring accurate documentation, compliance, and data integrity within the ERP system. This position involves creating PI sheets, verifying serological test results, cross-referencing TRP paperwork, and finalizing donor chart dispositions in accordance with regulatory standards.
Key Responsibilities:
  • ERP System Management: Create and maintain PI sheets in the ERP system, enter serological test results, and finalize donor chart dispositions based on Medical Director decisions.
  • Documentation Verification: Cross-reference TRP paperwork and labels with ERP system and RFID labels to ensure accuracy and compliance.
  • Regulatory Compliance: Interpret results following current procedures, state and FDA regulations, and AATB standards.
  • Metrics and Reporting: Track metrics for Medical Director deferrals and microbiological rejections; collaborate with QCPR and TR teams for process improvements.
  • Team Support: Assist in assembling detailed donor files, performing data entry, reconciling documents, and supporting Tissue Services Portal operations.
Qualifications:
  • High school diploma required; bachelor’s degree preferred.
  • 1–3 years of experience in the GMP industry, with a preference for medical or pharmaceutical fields.
  • Proficiency in data entry and familiarity with medical terminology.

Pay Range: $25/hr. - $27/hr.

Job Requirement
  • Data Entry
  • Regulatory Documentation
  • ERP Systems
  • Excel
  • GMP/cGMP
  • Quality Review
  • FDA
Reach Out to a Recruiter
  • Recruiter
  • Email
  • Phone
  • Vishnu Nair
  • vishnu.nair@collabera.com
Apply Now
Apply Now
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Collabera is a leading global digital talent solutions firm. For over 25 years, we have provided digital and IT talent services, direct placement and career advisement, global remote talent and learning solutions to transform and diversify workforces for the Fortune 1000 globally.

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