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:

• Organizational skills
• Ability to work in a fast-paced environment.
• Excellent attention to detail skills

Education & Experience:

• Bachelor’s degree in a biological science or related field required
• Prefer at least 1 year of experience in an FDA regulated environment for HCT/Ps and/or medical devices (or related field)