QA Batch Record Reviewer

VIVEX Biologics, Inc.; Miami, Northern (FL, KY); Hybrid; USD 65,000 - 85,000; Full time

Job summary

VIVEX Biologics, Inc. is seeking a QA Batch Record Reviewer to perform technical and final release for grafts. You will assemble and review manufacturing records, determine disposition, and ensure compliance with SOPs and AATB standards.

Attention to detail is essential in a quiet office environment with possible after-hours requirements. The role requires at least 3 years in quality assurance or related fields, AA or BS preferred, and certification as a Tissue Bank Specialist within 2 years of

Qualifications

• AA or BS degree preferred with knowledge of QA practices.
• Strong attention to detail in documentation and records.
• Familiarity with tissue processing and inventory processes.

Responsibilities

• Disposition, review, and verify tissue sent for irradiation and sterilization.
• Confirm quality control results are within acceptable limits.
• Ensure tissue labeling per manufacturer's specification sheet when required.
• Confirm packaging integrity and final labels pass inspections prior to final disposition.
• Review records for SOPs, regulatory and accreditation compliance.
• Communicate missing documentation and correct errors with relevant personnel.
• Monitor and track completion of all work-in-progress records.
• Update changes in tissue status in the inventory system.
• Collaborate with operations and customer service on inventory needs.
• Maintain proficiency with the VIVEX BTM computer system.
• Report variances, errors and deviations to Quality Assurance.
• Support in complaint and/or nonconformance reports as needed.
• Perform other duties as assigned by Manager and Director.

Skills

Quality Assurance

Documentation

Allograft handling

BTM system

Education

AA or BS preferred

Job description

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 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.

Duties and Responsibilities

1. 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

2. Work closely with operations and customer service personnel on inventory needs for customer orders and back orders.

3. Knowledgeable of the VIVEX BTM computer system and able to perform all functions as required.

4. Responsible for reporting all variances, errors and deviations to Quality Assurance.

5. Able to collaborate on complaint and/or nonconformance reports according to VIVEX procedure.

6. Performs other duties as assigned by the Manager and Director of the Department.

Requirements

Qualifications

• 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.

Working Conditions

Primarily a quiet office-oriented work environment. Some evening and weekend work may be required to ensure customer commitments and goals are met.

Physical Requirements

While performing the duties of this job, the employee is regularly required to sit for prolonged periods of time. The employee may occasionally be required to pull, lift and/or move up to 20 pounds.

Direct Reports

No direct reports.