About the role
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