What are the responsibilities and job description for the Quality Assurance Release Specialist position at MTF Biologics?
Overview
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.
Monday-Friday 8:15am-4:30pm
Responsibilities
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 non-conformances 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 re-train 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.
Qualifications
Degree/Diploma: BachelorsMinimum Years of Experience Area of experience:3 Years of Quality Assurance or manufacturing related management experience in a GMP regulated industry
Benefits Information
At MTF Biologics we provide comprehensive benefits and resources to support our employees physical, emotional, and financial health.
- 4 weeks Paid Time Off (PTO)
- Paid Holidays
- Medical, Dental, Vision Insurance and Prescription Drug Insurance
- 401K plan with company match
- Short & Long Term Disability
- Life & Accidental Death Insurance
- Tuition Reimbursement
- Health Care/Dependent Care Flexible Spending Accounts
- Adoption Assistance
- Voluntary Benefits (e.g., Pet Insurance, Legal, home and auto insurance)
- Sword Health (at home Physical Therapy)
