Donor Services Review Specialist

Purpose

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

Responsibilities

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

· Support internal and external audits

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

· Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures

· Maintain acceptable attendance and punctuality for scheduled work hours and meetings. Ensure completion of assigned tasks and responsibilities within defined timeframes

· Flexibility to work outside of normal business hours during weekdays or weekends with reasonable advance notice to support business/operational needs when necessary

· Perform other duties as assigned

Skills

· Ability to work independently and in a team environment

· Excellent attention to detail and organization

· Excellent written and verbal communication

· Highest level of ethics and integrity

· Ability to lead and motivate the right behaviors

· Ability to multi-task and work in a fast-paced environment

· Strong technical writing

· Effective project management

· Proficiency in Microsoft Office 

Qualifications/Requirements

· Bachelor’s degree in a biological science or related field Preferred or at least 3 years of experience in an FDA regulated environment for HCT/Ps and/or medical devices (or related field)

· Clearance of favorable background investigation required