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Ossium Health · 2 days ago

Quality Assurance Associate, Donor Quality

Greater Indianapolis

Full-time

Hybrid

Entry Level

2+ years exp

Ossium Health is dedicated to improving health through bioengineering and stem cell science. The Quality Assurance, Donor Quality Associate will manage donor documentation processes, ensuring accuracy and compliance while supporting the release of donated tissue.

BiotechnologyHealth CareLife Science

Growth Opportunities

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

Qualification

Quality Assurance experienceFDA regulationsMedical record reviewMicrosoft Office SuiteAdobe AcrobatGoogle DriveProfessionalismCTBS CertificationExperience in organ/tissue donationDetail-orientedCommunication skillsTime managementOrganizational skills

Required

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