Donor Services Coordinator I

Xtant Medical Holdings Inc•Belgrade, MT

5h•Onsite

About The Position

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.

Requirements

Must be able to reason independently and work with minimal guidance
Ability to interpret data and make sound judgements based on those interpretations
Must deal effectively with a wide variety of personalities and situations requiring tact, judgement, and poise
Must be able to adapt to quickly changing priorities and schedules
Ability to maintain good working relationships with all co-workers and the general public and use good judgement in recognizing scope and authority
Associate or bachelor’s Degree, preferably in science, from an accredited college or university is required or equivalent experience
One (1) year of experience that is directly related to the duties and responsibilities specified
Must be willing to acquire Certified Tissue Bank Specialist (CTBS) certification
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

Nice To Haves

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
Some experience with records maintenance and document control preferred

Responsibilities

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
Assist in the completion and retention of documentation pertaining to all SOPs as required
Legibly and accurately complete all documentation associated with assigned duties in accordance with GDP and review the written documentation of others as required
Train and demonstrate proficiency in Xtant Medical’s document control system
Maintain information in physical and electronic files as required
Perform duties and responsibilities to the highest standards with efficiency, professionalism, and attention to detail; adapt to job changes and contribute to team success
Maintain confidentiality of donor and recipient information according to HIPAA