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