Why Xtant Medical?
JOIN A RISING organization that is focused on the design, development, and commercialization of a comprehensive portfolio of orthobiologics and spinal fixation systems. Xtant Medical’s mission is to provide cost-effective technology and services that help clinicians efficiently perform their job.
Xtant Medical is seeking a talented and dedicated Donor Services Coordinator I that will support the company mission to market regenerative medicine products and medical devices. Xtant Medical is seeking talented and dedicated individual that will support the company mission to market regenerative medicine products and medical devices. Primary responsibilities of the Donor Services Coordinator will be to ensure unprocessed human tissue received at Xtant Medical is received, initially cultured, stored and tracked until it is approved for transplant, non-clinical use, or disposal. This position will have work hours that will fall after normal business hours, on weekends, and holidays. This position interacts with CLIA lab personnel and processing personnel and may interact with other departments and employees as required.
Principle Duties & Responsibilities
- Develop and maintain an understanding of the requirements of the Food and Drug Administration (FDA) Code of Federal Regulations Title 21, Parts 820 and 1271; American Association of Tissue Banks (AATB); International Organization of Standardization (ISO); European Medical Device Directives (MDD); and Canadian Medical Device Regulations, as applicable, and adhere to standards and regulations to help the company lead the Medical Device and Biologics industries in quality practice
- Adhere to Xtant Standard Operating Procedures (SOPs) and safety protocols, FDA Regulations for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) and Devices; operate in compliance with FDA, AATB, ISO, and Occupational Safety and Health Administration (OSHA) Standards
- Develop and maintain an understanding of the Xtant products and general biological and chemical systems utilized within the Department. Know how the activities performed in the Department are controlled by and interact with the Quality System and how they affect the production of medical devices and tissues as applicable
- Support Xtant Medical’s mission to design, manufacture, and distribute innovative, safe, reliable, and cost-effective solutions for the medical needs of patients
- Perform all duties according to SOPs and Good Documentation Practices (GDP) and follow appropriate safety precautions and measures
- Represent the company in a professional manner to the public, customers, and vendors and maintain trusting relationships with recovery partners, customers, and fellow employees
- Receive, inspect, and store unprocessed quarantined tissue when it arrives at Xtant Medical. This may include arranging delivery with a courier after hours, on weekends and holidays
- Receive and inspect procurement blood/serum/plasma samples and cultures from unprocessed donors. Samples will be forwarded to the Biologics Diagnostics Lab for testing or shipped to outside agencies
- Perform and document required cleaning of surfaces before and after donor 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 scheduled 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 work area, equipment and supplies for use, and following aseptic technique during all phases of tissue culturing
- Ensure all low-temperature freezers used to store 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
- Ensure that donor information is shared with Recovery Agencies in a timely manner
- Ability to write, review, and edit technical reports and SOPs
- Ability to communicate effectively both orally and in writing
- Ability to multitask
- Must possess excellent organizational skills and strong attention to detail
- Proficient computer skills required such as advanced knowledge of MS Word, Excel, PowerPoint, Outlook, and other software as necessary
- Ability to investigate and analyze information and to draw conclusions
- Some experience with records maintenance and document control preferred
- Associate or Bachelor’s Degree, preferably in science, from an accredited college or university is required or equivalent job-related work experience.
- Prior knowledge and experience in biologics manufacturing or other relevant cleanroom/aseptic environments preferred but not required.
- Some knowledge of FDA, ISO, and AATB requirements as applicable.
- Must be willing to acquire Certified Tissue Bank Specialist (CTBS) certification.
Benefits: Xtant Medical offers competitive wages, and comprehensive Medical, Vision, Dental, 401k, Life and AD&D, and Disability insurance packages
No H1B Sponsorships Available for this Position.
Xtant Medical is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, national origin, sex, age, disability, or any other status protected by law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions be based on job-related factors.