Advanced Quality Assurance Specialist
Bio-Techne
August 11, 2026
On-site
Austin, TX
Operations
Position Summary
The Advanced Quality Assurance Specialist will work with the Quality Assurance team to maintain and grow Asuragen’s Quality Management System in alignment with international quality and regulatory standards.
Key Responsibilities
- Support compliance with regulatory standards, systems, procedures, and practices (including ISO 13485, FDA QSR, MDSAP, IVDR, and other QA requirements).
- Provide QA support to project core teams.
- Support and/or own key quality management system processes.
- Conduct internal and external audits; summarize results and report to Quality Management.
- Assist in managing Document Control, Training, NCR, CAPA, Complaints, Internal Audits, and Supplier Management (may own one or more).
- Review and approve validation activities.
- Review and approve quality equipment calibrations and maintenance.
- Support regulatory and client audits.
- Support QA Department goals; generate metrics for Quality Management Reviews.
- Other duties as assigned.
Education And Experience
- Bachelor’s/Master’s degree in a related field; 4–6 years’ experience in a regulated manufacturing facility (or equivalent education and applicable work experience).
Knowledge, Skills, And Abilities
- Proficiency with Microsoft Office and database management programs.
- Detail-oriented; ability to prepare accurate records.
- Knowledge of QA principles in a manufacturing environment.
- Prioritization and ability to meet tight deadlines.
- Ability to train employees on procedures and QA concepts.
- Team-oriented; dispute resolution skills.
- Excellent written and oral communication.
- Strong analytical/problem-solving; independent work with minimal supervision.
- Familiarity with statistical tools in a regulated environment.
- Preferred: knowledge of cGMP, ISO 13485, MDSAP, IVDD/IVDR, and FDA QSR.
Benefits
- Competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield.
- 401k, ESPP, HSA, FSA, and Dependent Care FSA.
- Training and development; tuition reimbursement; paid leave and paid holidays; paid parental leave.
The Advanced Quality Assurance Specialist will work with the Quality Assurance team to maintain and grow Asuragen’s Quality Management System in alignment with international quality and regulatory standards.
Key Responsibilities
- Support compliance with regulatory standards, systems, procedures, and practices (including ISO 13485, FDA QSR, MDSAP, IVDR, and other QA requirements).
- Provide QA support to project core teams.
- Support and/or own key quality management system processes.
- Conduct internal and external audits; summarize results and report to Quality Management.
- Assist in managing Document Control, Training, NCR, CAPA, Complaints, Internal Audits, and Supplier Management (may own one or more).
- Review and approve validation activities.
- Review and approve quality equipment calibrations and maintenance.
- Support regulatory and client audits.
- Support QA Department goals; generate metrics for Quality Management Reviews.
- Other duties as assigned.
Education And Experience
- Bachelor’s/Master’s degree in a related field; 4–6 years’ experience in a regulated manufacturing facility (or equivalent education and applicable work experience).
Knowledge, Skills, And Abilities
- Proficiency with Microsoft Office and database management programs.
- Detail-oriented; ability to prepare accurate records.
- Knowledge of QA principles in a manufacturing environment.
- Prioritization and ability to meet tight deadlines.
- Ability to train employees on procedures and QA concepts.
- Team-oriented; dispute resolution skills.
- Excellent written and oral communication.
- Strong analytical/problem-solving; independent work with minimal supervision.
- Familiarity with statistical tools in a regulated environment.
- Preferred: knowledge of cGMP, ISO 13485, MDSAP, IVDD/IVDR, and FDA QSR.
Benefits
- Competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield.
- 401k, ESPP, HSA, FSA, and Dependent Care FSA.
- Training and development; tuition reimbursement; paid leave and paid holidays; paid parental leave.