Quality Assurance Specialist

Purpose
The Quality Assurance Specialist is responsible for ensuring compliance with all applicable regulatory, accreditation, and internal quality system requirements. This role provides critical oversight of documentation, production processes and procedures, environmental monitoring, and final product release to ensure the safety, quality, and traceability of human tissue. This role serves as a key quality influence supporting continuous improvement, audit readiness, and protection of donor intent and recipient safety.
Responsibilities
Review HCT/P donor records in accordance with standard operating procedures and regulatory requirements
Review quality control records to include equipment cleaning/maintenance, environmental monitoring, and supply inspections
Review HCT/P donor records for final product release in accordance with standard operating procedures and regulatory/accrediting agency requirements
Inspect, sort, and quarantine/discard HCT/P products in accordance with standard operating procedures and regulatory requirements
Identify and initiate quality events
Communicate and escalate inspection or quality control issues to Management when necessary
Support internal audits and support FDA and AATB Inspections Support development and revision of procedures/controlled documents according to FDA, AATB, and other applicable regulations
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
Associate degree from an accredited college or university in a biological science, engineering, or related field required; OR
2 years of experience in an FDA regulated environment for HCT/Ps, medical devices, pharmaceuticals, and/or related field may be substituted for the degree requirement
Bachelor’s degree in biological science, engineering, or related field preferred
Clearance of favorable background investigation required

Employment type
Full-Time

Work arrangement
No