Donor Services Coordinator

Classification: Full Time – Non-Exempt

Reports to: Donor Services Manager

This position is responsible for ensuring unprocessed human tissue received at Xtant Medical is received, cultured, stored, and tracked until it is approved for transplant, non-clinical use, or disposal.

This position reports to the Donor Services Manager. This position may provide additional support to supervisors or other departments as requested.

The work week for this position is Monday through Friday, 8:00am to 5:00pm with rotational on-call responsibilities. On-call responsibilities are shared with other team members and will require time outside of scheduled work hours, weekends, and holidays. This person does not supervise others and will support the activities of the department. This position interacts closely with Xtant Medical’s Medical Directors, CLIA Lab, and processing personnel and may interact with other departments and employees as required.

• This position does not supervise others

• Develop and maintain an understanding of relevant industry standards and regulations including but not limited to 21 CFR 820, 21 CFR 1271, AATB, MDSAP (per jurisdictional requirements), and ISO 13485, ensuring compliance with these requirements across the organization.
• Actively contribute to the fulfillment of Xtant Medical’s mission, values and quality policy
• Maintain a safe, clean work environment and ensure proper disposal of hazardous and non-hazardous waste according to OSHA guidelines and Xtant Medical standard operating procedures (SOPs)
• Develop and maintain an understanding of Xtant Medical products
• Understand the interaction of departmental activities with the Quality System and their impact on the production of medical devices and human cells, tissues, and cellular and tissue-based products (HCT/Ps)
• Adhere to Xtant Medical SOPs, Good Documentation Practices (GDP), and safety protocols
• Receive, inspect, and store unprocessed quarantined tissue when it arrives at Xtant Medical. This may include arranging pickup or delivery with a courier after hours, on weekends and on holidays
• Transfer tissue throughout the Xtant Medical campus as needed and perform required documentation of the transfer
• Ship unprocessed tissue to partners when necessary and update the Donor Database and Donor Chart as applicable
• Receive, inspect, and store procurement blood/serum/plasma samples and cultures from unprocessed donors. Samples will be stored, archived, and forwarded to the Xtant Medical CLIA Lab or shipped to outside agencies for testing as applicable
• Perform and document required weekly cleaning and cleaning of surfaces before and after donor tissue and sample inspection
• Ensure all unprocessed tissue deemed unacceptable is quarantined in such a manner that segregates it from unprocessed tissue whose status is undetermined or is released and available to be sent to processing
• Discard all unprocessed tissue deemed unacceptable in the appropriate biohazard container and complete all required documentation
• Perform aseptic culture sampling of donor tissue when necessary. Inspect all supplies and equipment prior to handling, aseptically set up a work area, equipment, and supplies for use, and follow aseptic technique during all phases of tissue culturing
• Ensure all low-temperature freezers and refrigerators used to store archive blood samples and unprocessed tissue have been approved for use and have the appropriate signage posted to indicate freezer status
• Receive and compile donor information into the final Donor Chart and complete the Donor Eligibility Assessment
• Communicate with Recovery Agencies and ensure that relevant donor information and records are shared with the applicable Recovery Agency in a timely manner
• Other duties as assigned

• Submit timely expense reports and abide by the Expense Reimbursement Policy

• Participate in training plans and programs and complete them in a timely manner within set deadlines
• Complete required training prior to attempting to perform a task
• Maintain required training documentation