What are the responsibilities and job description for the Donor Services Review Specialist position at Extremity Care?
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
