Donor Services Associate.
This position is a key member of the Aziyo Biologics team and as such is responsible for the timely and accurate compilation and technical review of donor records to ensure regulatory compliance.
This position will perform a wide variety of administrative activities associated with the functions of the Donor Services department to ensure compliance with Aziyo Biologics requirements, FDA regulations/guidance documents and AATB Standards.
This position will partner with Operations and Quality Assurance to ensure compliance with applicable regulations and accomplish company goals of restoring health and mobility to the greatest number of patients possible.
Position reports to the Manager, Donor Services Manager
Essential Duties & Responsibilities
- Acts as a key component of the Records Management process by compiling and maintaining donor records as they become available.
- Performs technical review of donor chart information for completeness and accuracy and ensures donor is in compliance with SOPs and applicable standards/regulations.
- Prepares finalized donor chart information for donor eligibility review.
- Extracts information from donor charts and enters information into the appropriate Aziyo Biologics systems.
- Communicates information to other departments with the ability to act as the primary departmental point of contact.
- Distributes information to procurement agency partners and processing centers as appropriate.
- Maintains documentation of in-process tissue as required, updating records and appropriate database systems at each step in the process.
- Maintains confidentiality of donor related information
High School Diploma or equivalent required, B.S. in Life Science or equivalent work experience preferred
Experience and Skills
- Minimum of two years of experience in a regulated industry required.
- Experience in a FDA-regulated environment, with knowledge of 21 CFR Part 1271, Human Cells, Tissues, and Cellular and Tissue-Based Products (HTC/P) preferred.
- Ability to understand and follow policies and procedures based on FDA, AATB, and OSHA regulations.
- Advanced PC, database and Microsoft Office skills.
- Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.).
- Excellent verbal and written communication skills.
- Ability to independently manage multiple tasks and prioritize work appropriately with a focus on timelines and deliverables.
- Ability to follow policies and procedures faithfully while constantly maintaining a proactive and critical eye on possible process improvements