Description. Job Purpose. The Quality Assurance (QA) Final Release Team Lead position supports the tissue batch final release processes. Performs functions necessary to assure that all relevant donor and manufacturing records and documentation are assembled, reviewed, and completed in a compliant efficient manner. This position requires attention to detail and must be performed in accordance with standard operating procedures, as well as all appl...
Description. Job purpose. Performs functions necessary to assure that Vivex Biologics, Inc. is in compliance with all applicable regulations and/or standards of regulatory and accrediting agencies. Performs functions necessary to assure that all relevant donor eligibility documentation are assembled, reviewed, and completed in a timely manner. Performs continuous review and inspection of donor chart records and ensures that such records are in th...
Description. Job purpose. The Quality Compliance Coordinator is primarily responsible for managing and monitoring Corrective Actions & Preventive Actions (CAPA), Non-conformances (NC), Supplier Corrective and Preventive Actions (SCAR), Complaints, Planned Deviations, and Error Corrections. Additionally, the Quality Compliance Coordinator is responsible for managing change controls related to manufacturing product, process, equipment, facility, et...
Description. . Job Purpose. The Operations Processing Supervisor reports to the Production Manager and supports the cleaning, cutting, inspecting, and packaging of Birth Tissue grafts. The Operations Processing Supervisor is responsible for scheduling their assigned team of technicians to meet the weekly production plan. The supervisor must be able to implement and sustain production metrics directly related to the company’s KPI while making proc...
Description. Job Purpose. The Quality Assurance (QA) Batch Record Reviewer performs the Technical and Final release function of the graft release process. The QA Batch Record Reviewer performs functions necessary to assure that all relevant manufacturing records are assembled, reviewed, and completed in a compliant efficient manner, and ultimately determines and documents the final disposition of each graft on the controlled batch records and in ...
Description. Job purpose. Prepare, pack, and wrap all instruments, packaging material, and equipment for sterilization. Ensure that all instruments, packaging material, and equipment are sterile and ready for use in a timely manner. Duties and responsibilities. Responsible for organizing and scheduling of sterile processing workload. Proper washing, disinfecting and sterilization of specific instruments utilized at Vivex Biologics, Inc. Must be a...
Description. Job purpose. The Inventory Coordinator is responsible for maintaining a high level of inventory accuracy and integrity within the Tissue Bank. Ensure that Inventory Control Operations are in Compliance with the State and Federal Regulations and AATB Standards. Promotes Lean Behaviors across the organization (This includes Participating in Try storming, Brainstorming and Lean Related Initiatives). Resourceful in completing deadlines a...
Description. Job Purpose. Ensure that all clean room maintenance is completed on a daily basis. In addition, all administration facility maintenance is completed as scheduled. Ensure the all storage equipment is maintained at the appropriate intervals. Also, to ensure that all equipment and supplies used throughout the tissue bank is maintained and ready for use. Duties and Responsibilities. Coordinate the activities of all facility maintenance w...
