Quality Release Specialist

Location

Edison, NJ | United States

Job description

The QA Release Specialist has responsibility for the final review of critical documentation and testing results for donor tissue and the authorization for the final release of that tissue and/or medical devices for transplantation/implantation. This position is responsible for establishing/updating procedures and best practices for MTF's system for reviewing and final release of donor tissue.

• Independently performs the conclusive and final review of critical documentation and testing results in accordance with current MTF procedures, finished good (FG) specifications, in-process finished goods (IFG) specifications. Reviews performed by QA Release Specialist are a critical part of MTF's systems for providing safe and high quality tissue and/or medical devices.
• Authorizes the final release of processed tissues or medical devices for transplantation/implantation or other disposition.
• Independently performs the conclusive and final review of donor charts associated with non-conformance issues (NCRs) following Final Disposition and Quality Assessment reviews. Communicates and coordinates with individuals from other business units to complete the necessary documentation, and ensure the deviations, discrepancies, or non­conformances have been resolved before the tissue or medical device units are released for transplantation/implantation.
• Independently performs the conclusive and final review and release for special request grafts, the graft matching program, individual tissue requests, and non-routine release of tissue or medical devices.
• Prioritizes review activities according to changing needs of MTF's business units.
• Identifies best practices for review of processing records according to regulatory requirements and lead changes with the business units and Quality Assurance for implementation.
• Mentors and trains new QA staff in performing documentation reviews and re­train existing staff on updates and/or changes to existing procedures.
• Establishes and maintains MTF's written procedures for review of donor documentation and disposition of tissue.
• Reviews the work of Quality Analysts for adherence to MTF's requirements.
• Assists on special projects, and perform additional duties, as assigned. 

• Bachelor's Degree
• 3 years Quality Assurance or manufacturing related management experience in a GMP regulated industry 
• Must be proficient in data entry, Microsoft Outlook, Word, and Excel
• Must exhibit attention to detail, organizational, critical thinking, problem solving People management
• Effective communication skills

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