HCT/P Quality Assurance & Compliance Specialist

Tiger BioSciences, LLC; San Antonio (TX); On-site; USD 52,000 - 72,000; Full time

Job summary

Tiger BioSciences, LLC is seeking a Quality Control Specialist to ensure HCT/P products and QC processes meet established quality requirements. The role emphasizes inspection, documentation, and regulatory compliance in a fast-paced environment.

Responsibilities include in-process and post-processing QC testing, preparing shipping documents, and maintaining environmental monitoring records. Candidates should have a biological sciences background and familiarity with FDA/regulatory standards.

Qualifications

• Bachelor’s degree in a biological science or related field required.
• At least 1 year of FDA-regulated environment experience preferred.
• Bachelor’s degree may substitute up to 4 years of experience; Master’s may substitute up to 6 years.

Responsibilities

• Inspect HCT/P products per SOPs and regulatory requirements.
• Sort and segregate acceptable and unacceptable products.
• Perform in-process and post-processing QC inspections and testing.
• Prepare shipping documents per SOPs.
• Communicate and elevate QC issues to Management/Quality Control.
• Initiate and review quality events and documentation.
• Assist in routing, editing, and finalizing controlled documents for compliance.
• Support internal and external audits.
• Maintain records per SOPs and regulatory standards.
• Maintain knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, ISO, cGMP/CGTP.

Skills

Attention to detail

Written communication

Independent work

Team collaboration

Quality control

Regulatory awareness

Documentation

Project management

Microsoft Office

Fast-paced environment

Education

Bachelor’s degree in Biological Science

Tools

Microsoft Office

Job description

Tiger BioSciences, LLC is seeking a Quality Control Specialist to ensure HCT/P products and QC processes meet established quality requirements. The role emphasizes inspection, documentation, and regulatory compliance in a fast-paced environment.

Responsibilities include in-process and post-processing QC testing, preparing shipping documents, and maintaining environmental monitoring records. Candidates should have a biological sciences background and familiarity with FDA/regulatory standards.