Quality Assurance Specialist

Extremity Care, LLC; San Antonio (TX); On-site; USD 60,000 - 85,000; Full time

Job summary

Extremity Care, LLC seeks a Quality Assurance Specialist to ensure regulatory compliance and quality system integrity for human tissue products. You will oversee documentation, production processes, environmental monitoring, and final product release to safeguard donor intent and recipient safety.

The role supports audits, FDA and AATB inspections, and continuous improvement. Strong technical writing, detail orientation, and teamwork are essential for success in a fast-paced setting.

Qualifications

• Associate degree in a biological science or related field.
• 2 years of FDA-regulated environment experience may substitute for the degree.
• Bachelor’s degree in biological science, engineering, or related field preferred.
• Clearance of favorable background investigation required.

Responsibilities

• Review HCT/P donor records in accordance with SOPs and regulatory requirements.
• Review quality control records including equipment cleaning, environmental monitoring, and inspections.
• Review donor records for final product release per SOPs and regulatory requirements.
• Inspect, sort, and quarantine/discard HCT/P products per procedures and regulatory rules.
• Identify and initiate quality events.
• Escalate inspection or quality control issues to management as needed.
• Support internal audits and FDA/AATB inspections; assist in procedure/document control updates.
• Maintain knowledge of FDA 21 CFR 1271, 21 CFR 820, AATB standards, ISO standards, and cGMP/CGTP.
• Maintain acceptable attendance and punctuality; complete tasks within set timeframes.
• Flexibility to work outside normal hours as needed for business needs.
• Perform other duties as assigned.

Skills

Attention to detail

Regulatory knowledge

Technical writing

Microsoft Office

Team collaboration

Communication

Problem solving

Education

Associate degree in biological science or related field

Bachelor’s degree preferred

2 years FDA-regulated environment experience may substitute for degree

Tools

Microsoft Office

Job description

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 escalte 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 communicationHighest 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