About the position
The Quality Assurance (QA) Batch Record Reviewer plays a critical role in the graft release process by performing both the Technical and Final release functions. This position is essential for ensuring that all relevant manufacturing records are meticulously assembled, reviewed, and completed in a compliant and efficient manner. The QA Batch Record Reviewer is responsible for determining and documenting the final disposition of each graft on the controlled batch records and within the VIVEX Biologics computer system. Attention to detail is paramount in this role, as all tasks must be executed in accordance with standard operating procedures, as well as all applicable state, regulatory, and AATB requirements. In this position, the QA Batch Record Reviewer will be tasked with meeting assigned goals in the technical release review and final release of allografts. This includes responsibilities such as the disposition, review, and verification of tissue sent for irradiation and sterilization, confirming that relevant quality control results are within acceptable limits, and ensuring that each tissue is labeled according to the manufacturer's specification sheet when required. Additionally, the reviewer must confirm that packaging integrity and final labels have passed the appropriate inspections prior to setting the final disposition. The role also involves reviewing and completing records to ensure compliance with applicable SOPs, agency requirements, accreditation standards, and regulatory regulations. Effective communication with appropriate personnel regarding missing documentation and error corrections is crucial. The QA Batch Record Reviewer will monitor and track the completion of all work in progress (WIP) records and manage changes in the status of allografts in the inventory system. Collaboration with operations and customer service personnel on inventory needs for customer orders and back orders is also a key aspect of this position. Familiarity with the VIVEX BTM computer system is necessary to perform all required functions. Furthermore, the reviewer is responsible for reporting all variances, errors, and deviations to Quality Assurance and collaborating on complaint and/or nonconformance reports according to VIVEX procedures. Other duties may be assigned by the Manager and Director of the Department as needed.
Responsibilities
- Perform Technical and Final release functions of the graft release process.
- Review and verify tissue sent for irradiation and sterilization.
- Confirm relevant quality control results are within acceptable limits.
- Ensure each tissue is labeled per manufacturer's specification sheet if required.
- Confirm packaging integrity and final labels have passed appropriate inspections prior to setting final disposition.
- Review and complete records ensuring compliance with applicable SOPs, agency requirements, and regulatory regulations.
- Communicate with appropriate personnel on missing documentation and error corrections.
- Monitor and track completion of all work in progress (WIP) records.
- Manage changes in status of allografts in the inventory system.
- Collaborate with operations and customer service personnel on inventory needs for customer orders and back orders.
- Utilize the VIVEX BTM computer system to perform all required functions.
- Report all variances, errors, and deviations to Quality Assurance.
- Collaborate on complaint and/or nonconformance reports according to VIVEX procedures.
- Perform other duties as assigned by the Manager and Director of the Department.
Requirements
- AA or BS preferred.
- Basic computer skills necessary.
- Minimum of three years' experience in quality assurance, processing, distribution, or inventory control departments preferred.
- Candidate should be certified as a Tissue Bank Specialist by the American Association of Tissue Banks within 2 years of employment.
