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:

$49,700.00 - $81,650.00

POSITION SUMMARY

The Quality Assurance Specialist will work closely with internal colleagues as a key member of the Quality Assurance team to maintain and grow R&D Systems Quality Management System in alignment with international quality and regulatory standards.

This position is responsible for managing NCs, Change Controls, coordinating CAPA activities, preparing and participating in customer audits, performing internal audits, quality data trending and product related quality assurance activities. This position will be focused on Hematology product quality.

ESSENTIAL FUNCTIONS

Facilitate NC (Non-Conformance), CAPA and Change Control Process

Customer communication

Review and approve documents, labels and other documentation.

Attend customer project meetings as QA representative

Manage the discontinuation process.

Assist in Customer and Regulatory audits.

Manage recall activities.

Perform Internal Audits.

Generate monthly metrics for reporting.

Perform other tasks as assigned.

JOB SPECIFICATIONS

Education and Experience:

This position requires a B.S degree in Biology related disciplines which provides for the background necessary to perform the work. 

Requires 0 to 5 years of experience in Quality Assurance and/or Regulatory Affairs. 

The candidate must be self-motivated and must have strong organizational skills, critical thinking skills, and be detail oriented. 

Must respond to inquiry and request in a timely manner.

A working knowledge of Microsoft Word and Excel are required. 

Must be able to work in a fast-paced environment, multi-task, and have good communication skills and interpersonal skills.

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.