Advanced QA & Regulatory Compliance Specialist

Bio-Techne Corp.; Austin (TX); On-site; USD 56,000 - 91,000; Full time

Benefits offered by this job

Insurance benefits from day one

401(k) + ESPP

Tuition reimbursement

Job summary

Bio-Techne Corp. is seeking an Advanced Quality Assurance Specialist to maintain and grow Asuragen’s Quality Management System in alignment with international quality and regulatory standards.

You will provide QA support to project teams, manage document control, training, CAPA, and audits while ensuring cGMP, ISO 13485, and FDA QSR compliance in a fast-paced manufacturing environment in Austin, TX.

Qualifications

• Bachelor's or Master's degree in a related field from an accredited college/university.
• 4–6 years of experience in a regulated manufacturing facility.

Responsibilities

• Ensure compliance with regulatory standards (ISO 13485, FDA QSR, MDSAP, IVDR).
• Provide QA support to project core teams and QA processes.
• Conduct internal/external audits and summarize results.
• Manage document control, training, NCR, CAPA, complaints, internal audits, supplier management.
• Review and approve validations and quality equipment calibrations.

Skills

QA principles

Auditing

Regulatory knowledge

Documentation

Statistical tools

Communication

Problem-solving

Teamwork

Training

Education

Bachelor's/Master's degree in related field

Tools

Microsoft Office

Database management

Job description

Bio-Techne Corp. is seeking an Advanced Quality Assurance Specialist to maintain and grow Asuragen’s Quality Management System in alignment with international quality and regulatory standards.

You will provide QA support to project teams, manage document control, training, CAPA, and audits while ensuring cGMP, ISO 13485, and FDA QSR compliance in a fast-paced manufacturing environment in Austin, TX.