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)