Quality Assurance Specialist - Regulatory & Audit Ready

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

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.