Vivex Biologics · 2 months ago
QA Batch Record Reviewer
Miami,FL,US
Full-time
Onsite
Mid Level
3+ years expVivex Biologics is a company focused on quality assurance in the biologics sector. The QA Batch Record Reviewer is responsible for the technical and final release of grafts, ensuring compliance with manufacturing records and regulatory standards.
BiotechnologyHealth CareTherapeutics
Responsibilities
Responsible for meeting assigned goals in technical release review and final release of allografts, including, but not limited to:
Disposition, review, and verify tissue sent for irradiation and sterilization
Confirm the relevant quality control results are within acceptable limits
Ensure that each tissue is labeled per manufacturer's specification sheet (if required)
Confirm packaging integrity and final label(s) have passed appropriate inspection(s) prior to setting final disposition
Review and complete records ensuring compliance with applicable SOPs, agency requirements and accreditation standards and regulatory regulations
Communicate with appropriate personnel on missing documentation and error corrections
Monitor and track to completion of all work in progress (WIP) records
Change in status of allografts in the inventory system
Work closely with operations and customer service personnel on inventory needs for customer orders and back orders
Knowledgeable of the VIVEX BTM computer system and able to perform all functions as required
Responsible for reporting all variances, errors and deviations to Quality Assurance
Able to collaborate on complaint and/or nonconformance reports according to VIVEX procedure
Performs other duties as assigned by the Manager and Director of the Department
Qualification
Required
Basic computer skills necessary
Preferred
AA or BS preferred
Prefer a candidate a minimum of three years' experience in quality assurance, processing, distribution or inventory control departments
Candidate should be certified as a Tissue Bank Specialist by the American Association of Tissue Banks within 2 years of employment
Company
Vivex Biologics
VIVEX Biologics' mission is to provide regenerative product solutions that help patients suffering from musculoskeletal injuries and wounds.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Chris Agle
President & COO Legacy Donor Services Foundation
Tim Ganey
Chief Science Officer
Recent News
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