Tissue Donation Specialist I/II
Organogenesis
Full-time
Remote friendly (Norwood, MA)
United States
$65,000 - $80,000 USD yearly
Clinical Research and Development
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Role Summary
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
- Bachelor's Degree in Biology, Life Sciences or Nursing required
- 5+ years of experience in a cGMP/clinical environment preferred
- 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
- Proven ability to communicate effectively with other departments
- Proven ability to represent the Organization with outside vendors
- ASQ, CQA certification preferred
Skills
- Communication with cross-functional teams
- Regulatory compliance and documentation management
- Process improvement and audit remediation
- Vendor relationship management
Education
- Bachelor's Degree in Biology, Life Sciences or Nursing