QA Batch Release Specialist – Allograft Compliance

Vivex Biologics; Miami (FL); On-site; USD 60,000 - 90,000; Full time

Job summary

Vivex Biologics in Miami, FL seeks a QA Batch Record Reviewer to lead the technical and final release of grafts. You will ensure all manufacturing records are assembled, reviewed, and completed in a compliant, efficient manner per SOPs and regulatory/AATB requirements.

This role requires extreme attention to detail, accurate documentation in the VIVEX BTM system, and collaboration with operations and customer service to address missing records, variances, and deviations while meeting customer

Qualifications

• AA or BS preferred.
• Three years in quality assurance, processing, distribution or inventory control is preferred.
• Tissue Bank Specialist certification within 2 years of employment is desirable.

Responsibilities

• Responsible for meeting goals in technical release review and final release of allografts.
• Disposition and verify tissue sent for irradiation and sterilization.
• Confirm QC results are within acceptable limits.
• Ensure tissue labeling complies with manufacturer specs.
• Verify packaging integrity and final labels pass inspections.
• Review records for SOP, regulatory and accreditation compliance.
• Communicate missing documentation and correct errors.
• Monitor WIP records and update status of allografts.
• Collaborate with operations and customer service on inventory needs.
• Operate and utilize the VIVEX BTM computer system.
• Report variances and deviations to QA and assist with nonconformance reports.
• Perform other duties as assigned by managers.

Skills

Attention to detail

Quality assurance

Documentation

Graft release knowledge

Education

AA or BS preferred

Tissue Bank Specialist certification

Tools

VIVEX BTM system

Job description

Vivex Biologics in Miami, FL seeks a QA Batch Record Reviewer to lead the technical and final release of grafts. You will ensure all manufacturing records are assembled, reviewed, and completed in a compliant, efficient manner per SOPs and regulatory/AATB requirements.

This role requires extreme attention to detail, accurate documentation in the VIVEX BTM system, and collaboration with operations and customer service to address missing records, variances, and deviations while meeting customer