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 applicable state, regulatory and AATB requirements.

Duties and Responsibilities

1. Maintain the flow of work, to include but not limited to, the setup of donor and technical records for review, inspection of allografts and change in status of allografts in the inventory system.
2. Assign and track to completion all work in progress (WIP) records.
3. Attend weekly planning meeting as the Quality Assurance representative and work with Operations, Customer Service, Distribution and all other cross functional departments to ensure commitments and customer needs are met. 
4. Knowledgeable of the VIVEX Biologics’ BTM computer system and able to perform all functions as required.
5. Able to complete a Nonconformance Report and/or deviation according to VIVEX Biologics procedure.
6. Responsible for the QA review for BTM data entry, documentation, and technical and final release of autografts.
7. Ensure that each tissue is inspected per manufacturer’s specification sheet (if required), packaging integrity and final label(s) prior to setting final disposition.
8. Review and complete records ensuring compliance with applicable SOPs, agency requirements and accreditation standards and regulatory regulations.
9. Communicates with appropriate personnel on missing required documentation, error corrections required to ensure complete chart creation for QA, Medical Director review.
10. Assists in training the QA Final Release Team and monitors team performance for opportunities for improvement.
11. Responsible for reporting QA variances, errors and deviations on all VIVEX Biologics initiated documentation to Quality Assurance Department.
12. Performs other duties as assigned by the Manager and Director of the Department.

Requirements

Qualifications

AA or BS preferred. Candidate should be certified as a Tissue Bank Specialist by the American Association of Tissue Banks within 2 years of employment. Prefer a candidate with a minimum of three years’ experience in tissue banking, preferably in the quality assurance, processing, distribution or inventory control departments.

Working Conditions

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; stand 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.