biotechne
Advanced Quality Assurance Specialist
At a Glance
- Location
- Austin, Texas, United States
- Work Regime
- onsite
- Employment
- Full time
- Experience
- 4–6 years
- Compensation
- disease worldwide. Pay Range: $55,600.00 - $91,450.00 Position Summary: The Advance
- Posted
- 2026-08-11
Key Requirements
Required Skills
Domain Knowledge
- Manufacturing
Requirements
Knowledgeable in QA principles and concepts in a dynamic manufacturing facility
Familiarity with statistical tools and concepts and their application in a regulated environment.
Knowledge of cGMP, ISO 13485, MDSAP, IVDD/IVDR and FDA QSR preferred.
Responsibilities
The Advanced Quality Assurance Specialist will work closely with internal colleagues as a key member of the Quality Assurance team working to maintain and grow Asuragen’s Quality Management System in alignment with international quality and regulatory standards.
Provides support ensuring compliance with all regulatory standards, systems, procedures, and practices. Includes ISO 13485, FDA QSR, MDSAP, IVDR, and other requirements relating to Quality Assurance activities:
Provide QA support to project core teams.
Provide support to or ownership of key quality management system processes.
Conducts internal and external audits, summarizing the results and providing summaries to Quality Management.
Assists in the management of Document Control, Training, NCR, CAPA, Complaints, Internal Audits, and Supplier Management systems.