Senior Quality Assurance Specialist

Asuragen, Inc.; Austin (TX); On-site; USD 78,000 - 129,000; Full time

Benefits offered by this job

Competitive benefits on day one

401(k) plan and ESPP

Tuition reimbursement and development

Job summary

Bio-Techne is seeking a Senior Quality Assurance Specialist to enhance the Quality Management System in line with global standards. You will collaborate with internal teams to ensure product quality, lead audits, and drive continuous improvement across QA processes.

The role emphasizes regulatory knowledge, training delivery, and cross-functional leadership within a regulated manufacturing environment.

Qualifications

• Bachelor’s or Master’s degree in a related field with relevant regulated manufacturing experience.
• 7–10 years (Bachelor) or 4–6 years (Master) in a regulated facility is expected.
• Strong knowledge of QA, ISO 13485, FDA QMSR, MDSAP and related standards.

Responsibilities

• Lead compliance with regulatory standards, systems, procedures and practices.
• Oversee QA production reviews, approvals and product releases.
• Represent QA in new product design and development teams.
• Lead external audits and communicate results to QA management.
• Manage Document Control, Training and production QA activities.
• Direct NCR, CAPA, Complaints, Internal Audits and Supplier Management systems.
• Review and approve validation activities and equipment maintenance records.

Skills

QA principles and concepts

Auditing & regulatory compliance

Documentation control

Training & CAPA management

Statistical tools usage

Cross-functional collaboration

Excellent communication

Education

Bachelor's degree in a related field

Master's degree in a related field

Tools

Microsoft Office

Database management

Job description

By joining Bio-Techne, you’ll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.

Pay Range: $78,100.00 - $128,500.00

Position Summary

The Senior Quality Assurance Specialist will work closely with internal colleagues as a key member of the Quality Assurance team working to maintain and continuously improve Asuragen’s Quality Management System in alignment with international quality and regulatory standards.

Key Responsibilities

• Lead support for compliance with all regulatory standards, systems, procedures, and practices.
• Includes ISO 13485, FDA QMSR, MDSAP, IVDR, and other requirements relating to Quality Assurance activities.
• Execute QA production reviews, approvals and product release.
• Act as QA lead representative in new product design and development teams.
• Lead external audits, summarizing the results and providing summaries for Quality management.
• Execute Document Control, Training and QA Production related quality system activities.
• Lead the management of Training, NCR, CAPA, Complaints, Internal Audits, and Supplier Management quality systems.
• Responsible for the management of one or more of these systems.
• Reviews and approves validation activities.
• Reviews and approves controlled equipment calibrations and maintenance records.
• Support QA management in managing and driving Quality Objectives and Goals.
• Lead Quality Management Reviews.
• Identify and communicate risks to management with proposed mitigation plans.
• Create and conduct training for new QA team members.
• Other duties as assigned.

QUALIFICATIONS

• Education and Experience Bachelor’s degree in a related field from an accredited four-year college or university & 7-10 years of experience in a regulated manufacturing facility; or a combination of educational and applicable work experience.
• Master’s degree in a related field from an accredited four-year college or university 4-6 years of experience in a regulated manufacturing facility; or a combination of educational and applicable work experience.

Knowledge, Skills, and Abilities

• Skilled in the use of software programs such as Microsoft Office and database management programs.
• Detail oriented and skilled at examining documents for accuracy and completeness.
• Ability to prepare records in accordance with instructions.
• Knowledgeable in QA principles and concepts in a dynamic manufacturing facility.
• Ability to work in a fast paced environment.
• Ability to set priorities and meet deadlines on a personal level.
• Ability to work under tight deadlines.
• Capability to effectively train employees on procedures, processes, and QA concepts.
• Team oriented individuals with the ability to work effectively with multiple skill level employees.
• Skilled at dispute resolution.
• Excellent written and oral communication skills.
• Excellent analytical and problem-solving skills with the ability to work independently with minimal supervision.
• Familiarity with statistical tools and concepts and their application in a regulated environment.
• Ability to lead projects with cross functional teams.
• Ability to lead audits and reviews of processes.
• Knowledge of molecular science fundamentals, cGMP, ISO 13485, MDSAP, IVDD/IVDR and FDA QMSR preferred.

Why Join Bio-Techne:

• We offer competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield.
• We invest in our employees’ financial futures through 401k plans, an employee stock purchase plan (ESPP), Health Saving Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA.
• We empower our employees develop their careers through mentorship, promotional opportunities, training and development, tuition reimbursement, internship programs, and more.
• We offer employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging.
• We offer an accrued leave policy with paid holidays, paid time off, and paid parental leave.
• We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.
• Bio-Techne is an E-Verify Employer in the United States.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

To protect the interests of all, Bio-Techne will not accept unsolicited resumes from any source other than a candidate application.

Any unsolicited resumes sent to Bio-Techne will be considered Bio-Techne property.

This position requires work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States (e.g., H1-B visa, F-1 visa (OPT), TN visa or any other non-immigrant work status).

If you require a reasonable accommodation to complete an application, participate in an interview, or take part in any other stage of the recruitment process, please contact [e-mail] for assistance.

Bio-Techne empowers researchers in Life Science and Clinical Diagnostics by providing high-quality reagents, instruments, custom manufacturing, and testing services. Our family of brands creates a unique portfolio of products and services. Science is our passion; it drives us to collaborate, develop, and manufacture award-winning tools that help researchers achieve reproducible and consistent results.