Donor Services Review Specialist
| Position Title: | Donor Services Review Specialist |
| Department: | Quality Assurance |
| Reports To: | Donor Services Manager |
| Job Type: | Full Time |
| Shift: | Monday-Friday 8:00am-5:00pm |
| 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:
- 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).
Ability to commute/relocate:
San Antonio, TX 78249: Reliably commute or planning to relocate before starting work (Required)
Work Location: On location