Senior Quality Assurance Specialist

Bio-Techne; Austin (TX); In loco; USD 78.000 - 129.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical insurance

Dental insurance

Vision insurance

401k plan

Employee stock purchase plan

Descrizione del lavoro

Bio-Techne is seeking a Senior Quality Assurance Specialist to join the Quality Assurance team in Austin, TX. The role focuses on maintaining and improving the Quality Management System in line with international standards, with direct involvement in product release and audits.

The position requires leadership in QA activities, strong knowledge of regulatory frameworks, and ability to collaborate with cross-functional teams to drive continuous quality improvements.

Competenze

• Bachelor’s or Master’s degree with relevant regulated manufacturing experience.
• Experience with ISO 13485, FDA QMSR, MDSAP, IVDR is preferred.
• Ability to lead audits and reviews of processes.

Mansioni

• Lead regulatory compliance efforts across QA systems and practices (ISO 13485, FDA QMSR, MDSAP, IVDR).
• Execute QA production reviews, approvals and product release.
• Act as QA lead in design and development teams.
• Lead external audits and summarize results for QA management.
• Manage Document Control, Training and QA production related activities.
• Oversee Training, CAPA, NCR, Complaints, Internal Audits and supplier quality systems.

Conoscenze

QA principles

Statistical tools

Excellent communication

Detail oriented

Cross-functional teamwork

Auditing

Formazione

Bachelor's degree in a related field

Master's degree in a related field

Descrizione del lavoro

In-person

Austin, TX

Full time

JR102193

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.