Donor Services Review Specialist
| Position Title: | Donor Services Review Specialist |
| Department: | Quality Assurance |
| Reports To: | Donor Services Review Manager |
| Job Type: | Full Time |
| Shift: | Monday - Friday 08:00 AM - 05:00 PM |
| Exempt / Non-Exempt: | Exempt |
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)