QA Specialist: Regulatory Compliance & Release

Tiger BioSciences, LLC; San Antonio (TX); On-site; USD 60,000 - 90,000; Full time

Job summary

Tiger BioSciences, LLC in San Antonio, TX seeks a Quality Assurance Specialist to ensure regulatory and internal quality system compliance. You will oversee documentation, production processes, environmental monitoring, and final product release to protect donor intent and recipient safety.

The role involves reviewing donor records, quality control data, performing inspections, and supporting audits and FDA/AATB inspections. Strong attention to detail and solid writing skills are essential.

Qualifications

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

Responsibilities

• Review HCT/P donor records per SOPs and regulatory requirements.
• Review quality control records including equipment cleaning, environmental monitoring, and supply inspections.
• Inspect, sort, and quarantine HCT/P products per regulatory requirements.
• Identify and initiate quality events.
• Support internal audits and FDA/AATB inspections.
• Maintain knowledge of FDA 21 CFR 1271, 820, AATB, ISO, cGMP/CGTP.

Skills

Independent work

Attention to detail

Written communication

Ethics

Leadership

Multi-tasking

Technical writing

Project management

Microsoft Office

Education

Associate degree in biological science / engineering

Bachelor’s degree in biological science / engineering (preferred)

Job description

Tiger BioSciences, LLC in San Antonio, TX seeks a Quality Assurance Specialist to ensure regulatory and internal quality system compliance. You will oversee documentation, production processes, environmental monitoring, and final product release to protect donor intent and recipient safety.

The role involves reviewing donor records, quality control data, performing inspections, and supporting audits and FDA/AATB inspections. Strong attention to detail and solid writing skills are essential.