QA Batch Record Reviewer
About The Position
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 the VIVEX Biologics computer system. This position requires attention to detail and must be performed in accordance with standard operating procedures, as well as all applicable state, regulatory and AATB requirements.
Requirements
- AA or BS preferred. Basic computer skills necessary.
- 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.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
