Advanced Quality Assurance Specialist

Asuragen, Inc.; Austin (TX); On-site; USD 56,000 - 91,000; Full time

Benefits offered by this job

Competitive benefits from day one

401k + ESPP

Job summary

Bio-Techne, through its Asuragen brand, seeks an Advanced Quality Assurance Specialist to advance the Quality Management System in alignment with ISO 13485, FDA QSR, MDSAP and IVDR requirements, ensuring product quality and compliance.

You will collaborate with project teams, perform internal and external audits, manage document control, CAPA, NCRs and supplier quality, and help train staff while maintaining metrics for Quality Management Reviews.

Qualifications

• Bachelor's or Master's degree in a related field.
• 4-6 years of experience in a regulated manufacturing facility or equivalent.
• Experience implementing ISO 13485, FDA QSR, and related regulatory standards.

Responsibilities

• Ensures compliance with regulatory standards, systems, procedures, and practices.
• Supports internal and external audits and summarizes results for Quality Management.
• Manages Document Control, Training, NCR, CAPA, Complaints, Internal Audits, and Supplier Management.

Skills

QA principles

ISO 13485

FDA QSR

MDSAP

cGMP

Audits

Data analysis

Documentation

Training

Regulatory compliance

Education

Bachelor's or Master's degree in 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

$55,600.00 - $91,450.00

Position Summary

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.

Key Responsibilities

• 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.
• May be responsible for the management of one or more of these systems.
• Reviews and approves validation activities.
• Reviews and approves quality equipment calibrations and maintenance.
• Supports regulatory and client audits.
• Supports the overall QA Department goals.
• Generates metrics in support of Quality Management Reviews.
• Other duties as assigned.

Education and Experience

Bachelors/Masters 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 detailed instructions.
• Knowledgeable in QA principles and concepts in a dynamic manufacturing facility
• 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 individual 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.
• Knowledge of cGMP, ISO 13485, MDSAP, IVDD/IVDR and FDA QSR 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.