The Tissue Donation Specialist is responsible for management of all activities related to the Neonatal Foreskin Tissue Donation Program (NFTDP) and the Human Placental Tissue Donation Program (HPTDP) at Organogenesis. This includes, but is not limited to, auditing of files at approved donor sites, management of vendor relations with testing facilities (VRL & American Red Cross), supply management and coordination of file reviews with Tissue Bank Medical Director (TBMD) and/or designee.
Major Duties and Responsibilities: Assist in the coordination and alignment of Tissue Procurement operations with company goals and objectives. Plan, coordinate, and oversee daily operation of the Tissue Procurement procedures in conjunction with the organization's managers and supervisors.
Ensure compliance with SOP’s are followed for the execution of all aspects of the tissue programs (NFTDP & HPTDP), including all qualified sites and internal resources.
Ensure that all activities in the NFTDP and HPTDP are carried out in compliance with local, state, and federal regulations and laws governing business operations through communications with Regulatory Affairs.
Ensure programs comply with Good Tissue Practices, FDA HCT/P requirements, AATB and local and state regulations through communications with Regulatory Affairs.
Ensure Tissue Procurement practices (processes & methods) and policies comply with external regulatory requirements and internal organizational expectations.
Assist in the execution of corrective measures to remedy deficiencies cited in audits of the tissue programs.
Responsible for ensuring all appropriate tissue program documents are current and updated as required and that documentation is consistently produced with a high level of accuracy and clarity.
Assist in the development of Tissue Procurement operations financial strategies by estimating, forecasting, and anticipating requirements, trends, and variances; aligning monetary resources; developing action plans; measuring and analyzing results; initiating corrective actions; minimizing the impact of variances.
Coordinate the file reviews with the Tissue Bank Medical Director (TBMD) and/or designee.
Ensure that testing supplies are within expiry, coordinate and send supplies to sites as needed and track all materials in house and at donor sites
Provide needed records to the tissue donation sites and schedule the timely auditing of completed forms.
Audit donation sites for Donor medical records and assessment records, site audits and Regulatory binder audits
Assist in the identification, qualification and initiation of new donation sites.
Preferred Education and Experience:
5+ years of experience in a cGMP environment
Bachelor's Degree in Biology, Life Sciences or Nursing required
Previous experience with medical charts/medical terminology strongly preferred
Strong knowledge of Tissue Procurement and Cell Banking Operations, through a combination of experience and education required
Proven ability to communicate effectively with other departments
Proven ability to represent the Organization with outside vendors
ASQ certification preferred
Additional Salary Information: Salary expectations/range will be discussed in initial conversation to ensure alignment.
Internal Number: 616
Organogenesis is a leading regenerative medicine company focused on empowering healing through the development, manufacturing and sale of products for the advanced wound care, and surgical and sports medicine markets.
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