RegenTX, LLC · 9 hours ago
Quality Assurance Specialist
San Antonio, Texas, United States
Full-time
Onsite
New Grad, Entry Level
0+ years expRegenTX, LLC is seeking a Quality Assurance Specialist responsible for ensuring compliance with regulatory and internal quality system requirements. The role involves oversight of quality documentation and processes to ensure the safety and quality of human tissue while supporting continuous improvement and audit readiness.
Biotechnology
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 HCT/P products in accordance with standard operating procedures and regulatory requirements
Sort and segregate acceptable and unacceptable HCT/P products
Identify and initiate quality events
Communicate and escalate inspection or quality control issues to Management when necessary
Support internal/external audits recommended: Conduct internal audits; support FDA & AATB inspections
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
Qualification
Required
Associate degree (or 60 hours from an accredited college or university) in a biological science, engineering, or related field required
Valid Class C Driver's license
Clearance of favorable background investigation required
Preferred
At least 0-2 years of experience in an FDA regulated environment for HCT/Ps, medical devices, pharmaceuticals, and/or related field preferred
Bachelor's degree in biological science, engineering, or related field preferred
2 years of relevant work experience may be substituted for the degree requirement
Company
RegenTX, LLC
At RegenTX, we are blessed with the opportunity to maximize the gift of tissue donation.
Founded in 2015San Antonio, TX, US
11-50 employeesFunding
Current Stage
Early StageCompany data provided by crunchbase