Tissue Donation Specialist I II

Role Summary

Responsible for management of all activities related to the Birth Tissue Donation Program (HPTDP) at Organogenesis. This includes the compilation and auditing of donor files from approved Tissue Acquisition Organizations (TAOs), management of vendor relations with approved laboratories and TAOs, and coordination of file reviews with the Tissue Bank Medical Director (TBMD) and Quality Assurance. Once proficient in the management of the HPTDP cross-training on the Neonatal Foreskin Tissue Donation Program (NFTDP) will occur.

Responsibilities

• Assist in the coordination and alignment of Tissue Procurement operations with company goals and objectives.
• Planning, coordination, and oversight of daily operation of the Tissue Procurement procedures in conjunction with the organization's managers and supervisors.
• Ensure compliance with SOPs 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.
• Coordinate the file reviews with the Tissue Bank Medical Director (TBMD) and Quality Assurance.
• Assist in the identification, qualification and initiation of new donation sites.

Qualifications

• Required: Bachelor's Degree in Biology, Life Sciences or Nursing.
• Preferred: 5+ years of experience in a cGMP/clinical environment.
• Preferred: Previous experience with medical charts/medical terminology.
• Strong knowledge of Tissue Procurement and Cell Banking Operations, through a combination of experience and education.
• Proven ability to communicate effectively with other departments.
• Proven ability to represent the Organization with outside vendors.
• Preferred: ASQ, CQA certification.

Skills

• Communication and cross-functional collaboration
• Vendor management and relationship building
• Regulatory compliance and liaison with Regulatory Affairs
• Tissue procurement and cell banking operations knowledge
• Documentation accuracy and quality control
• Project coordination and process improvement