Purpose:

The Donor Services Review Specialist is responsible for reviewing HCT/P donor records for acceptability.

Duties & Responsibilities:

· Review HCT/P donor records in accordance with standard operating procedures and regulatory requirements.

· Inspect HCT/P products in accordance with standard operating procedures and regulatory requirements.

· Sort and segregate acceptable and unacceptable HCT/P products.

· Prepare shipping documents and packages in accordance with standard operating procedures based on order requests.

· Communicate and escalate quality issues to Management, as necessary.

· Support internal and external audits.

· File and maintain donor records and maintenance logs in accordance with standard operating procedures.

· Maintain working knowledge of regulatory requirements.

· Perform other related duties as assigned.

Skills & Abilities:

· Excellent attention to detail

· Organized

· Ability to work in fast paced environment

Education:

Bachelor’s degree in a biological science or related field required.

Experience:

Prefer at least 1 year of experience in an FDA regulated environment for HCT/Ps and/or medical devices (or related field).