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About Ossium
Ossium’s mission is to improve the health, vitality, and longevity of human beings through bioengineering. We develop, manufacture, and bank cell therapy products that apply the power of stem cell science to revolutionize treatment for patients with blood, immune, and orthopedic diseases. At Ossium, we empower our employees, maintain the highest standards of operational excellence, and are a force for good.
About the Job
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.
Required Qualifications
- 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
Preferred Qualifications
- Previous experience in organ/tissue donation industry
- CTBS (AATB) Certification
Key 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
In your first six months some projects you’ll work on include:
- 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
We offer a full slate of employee benefits including:
- Competitive salaries
- Stock options
- 401(k) matching
- Medical, dental and vision coverage
- Four weeks of PTO accrued (vacation & sick time) annually + 11 company holidays
- Employer paid life insurance and long term disability
- Gym membership/recreational sports reimbursements
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