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.

Position Summary:

The responsibilities of the Quality Assurance & Regulatory Affairs Specialist position are to assist senior quality staff to ensure adherence to site’s Quality Management System, serving as primary contact for quality and regulatory issues related to assigned products.

Key Responsibilities:

• Participate in team meetings as quality and regulatory representative and assist in management of quality and regulatory issues (new product design, data reviews or root cause investigations)
• Work collaboratively with all functions to ensure understanding and conformance with quality and regulatory requirements
• Prepares reports and necessary documentation to internal and external stakeholders to include
  • complaint investigations, supplier corrective action requests, corrective and preventative actions
• Participate in external audits by regulatory authorities, notified body, and customers
• Develop and/or maintain device master records for products to fulfill customer requests
• Review newly written or revised GMP specifications, documents, labels and literature for accuracy and completeness and write documents as needed
• Monitor quality systems through monthly complaint meetings, reports, trending and annual quality review
• Propose process improvements and areas for improvement to supervisor
• Follows company policies and practices, understand appropriate lab protocols and follow standard operating procedures (SOPs) including regulatory awareness of chemical handling and hazards, compliance, and proper use of equipment
• Performs additional duties as assigned

Education and Experience:

• An Associate degree with 3-5 years of relevant experience;
• Or, a Bachelor's degree with up to 3 years of relevant experience

Knowledge, Skills and Abilities:

• Attention to detail and organizational skills are required
• Working knowledge of Microsoft Word and Excel are required
• Computer entry, typing, or electronic document filing skills are required.
• Must be able to work in a fast-faced environment where multitasking is required
• Must have excellent verbal and written communication skills
• Knowledge of technical, regulatory, quality and production management systems
• Knowledge of documentation principles and processes
• Skills in accuracy, clarity and proofreading
• Skills in problem solving, identifying root cause and appropriately evaluate a course of actions

Why Join Bio-Techne:

• Competitive Compensation Packages, as we offer competitive salaries/pay, bonus programs, and generous PTO plans.
• We invest in our employees’ financial futures through 401k matching and an employee stock purchase plan.
• Complete Health Coverage - we offer full medical, dental, and vision benefits starting on day one for you and your family!
• We believe in taking care of our employees through benefits such as paid parental leave and on-site gym access.
• Community/Culture - we offer employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging.
• We foster a culture based in our EPIC values – Empowerment, Passion, Innovation, and Collaboration.
• Career Development - we are a quickly growing, global biotechnology company that offers lucrative career paths and development opportunities through mentorship programs, training and development initiatives, leadership programs, internship programs, and more.
• At Bio-Techne, you’ll be surrounded by colleagues that will inspire you to push yourself to the next level, and leadership that will value your new thoughts and ideas.
• We help our employees develop their careers through mentorship, promotional opportunities, training and development, internship programs, and more.

Where permitted by applicable law, candidate must have received or be willing to receive an FDA authorized COVID-19 vaccine by date of hire to be considered for this position.

Bio-Techne is an E-Verify Employer in the United States.