Tissue Donation Specialist I/II
Job Req code: 936
Category: Manufacturing Operations
Organogenesis corporate headquarters is located in Canton, Massachusetts, including manufacturing, R&D, customer service, reimbursement and other corporate teams supporting our full range of products. We have unique opportunities and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing.
This position reports to the Manager, Donor Services and works a Monday-Friday schedule during regular business hours.
- 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
- 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
- ASQ certification preferred
- Proven ability to communicate effectively with other departments
- Proven ability to represent the organization with outside vendors
- Remaining in a sitting position for long periods of time.
- Repeating motions that may include the wrists, hands, and/or fingers.
- Working indoors
- No adverse environmental conditions
- Sedentary work - exerting up to 10 pounds of force occasionally or an amount of force frequently to lift, carry, push, pull, or otherwise move objects. Sedentary work involves primarily sitting most of the time.
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