Quality Assurance Associate, Donor Quality

Ossium Health•Indianapolis, IN

1d•Hybrid

About The Position

The Quality Assurance, Donor Quality Associate will strengthen the foundation of Ossium’s donor documentation processes. You will handle communication between recovery partners, medical reviewers, and quality assurance staff using our electronic document tracking system. You will manage document intake and organize the donor records in preparation for chart review and eligibility determination. Your attention to detail directly supports the safe release of donated tissue. As you train your quality eye to confidently recognize various recovery partner-specific records, you will also review donor charts to ensure accuracy and alignment with regulatory and quality standards. If you love detail-oriented work, thrive in a fast-paced environment, and want to make a real impact in healthcare, this is your chance to be part of something meaningful—helping turn generosity into life-changing outcomes. This position reports to the Associate Supervisor, Donor Quality.

Requirements

Associate’s degree in Life Sciences or Chemistry and 2+ years of experience in Quality
Experience in reviewing medical records and understanding of medical technology
Ability to quickly and accurately organize and review large amounts of documentation
Capable of effectively assimilating information from visual inspection, written documents and verbal inputs and identifying potential compliance risks
Extremely detail-oriented
High level of professionalism and good judgment
Knowledge of FDA regulations
Proficient in Microsoft Office Suite, Adobe Acrobat, and Google Drive
Excellent written and oral communication skills
Capability to operate with a high level of organization and excellent time management in a dynamic startup environment
This position is based in our Indianapolis office; you will report to Ossium’s facility Monday through Thursday and have the option to work remotely on Fridays

Nice To Haves

Previous experience in organ/tissue donation industry
CTBS (AATB) Certification

Responsibilities

Process incoming emails and documentation sharing from recovery partners until a complete chart is obtained
Enter missing documentation on pending list and maintains document statuses in electronic document tracking system
Communicate in a timely manner to the chart review team when new information is received
Perform and manage reviews of recovery partner donor records, including follow-up activities to complete chart audits
Manage donor status and associated notifications within the document tracking system
Maintain knowledge of all required regulations
Explore opportunities to add value to quality department goals
Assist in the development of new reference materials as you become familiar with each of the recovery partner’s processes
Work closely with the Donor Quality Assurance team to standardize methods for document submission
Contribute towards various process improvement initiatives