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Quality Assurance Specialist

Job Details

Entry
Minneapolis MN - Minneapolis, MN
Full Time
Bachelor's Degree
Negligible
Day
Quality & Regulatory

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.

Position Summary:

The responsibilities of this position are to engage and support various improvement projects for Document Control (Label design and document writing, routing, approval etc) and Quality Assurance activities, including but not limited to Supplier Management, Non-Conformance, CAPA and Change Management etc.

ESSENTIAL FUNCTIONS

  • Perform label design, label feasibility testing and label approval
  • Facilitate in document migration projects from one system to another.
  • Perform Supplier Qualifications and Migration from one system to another.
  • Microsoft Dynamics AX Model item approval.
  • Assist Document Control by routing documents and completing projects.
  • Managing Change, Non-Conformance and CAPA activities.
  • Perform internal audits.
  • Perform other tasks as assigned.

Qualifications

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 Regulatory Affairs.  The candidate must have strong organizational skills, detail orientation, and critical thinking skills.  Must respond to inquiry and request in a timely manner. Working knowledge of Microsoft Word and Excel are required.  Computer entry and/or typing skills are desirable.  Must be able to work in a fast-paced environment, multi-task, and have good communication skills, both verbally and in writing.

 

Knowledge, Skills and Abilities:

  • Knowledge of ISO13485, ISO9001 and MDSAP Compliance.
  • Knowledge of Quality Assurance and Regulatory Affairs principles.
  • Knowledge of safety and company procedures and practices.
  • Knowledge of lab equipment & techniques.
  • Skills in managing projects.
  • Skills in coordination with Manufacturing departments.
  • Skills in problem solving; including the ability to identify and appropriately evaluate a course of action. 
  • Skills in trouble shooting and critical thinking.
  • Ability to be flexible.
  • Ability to act independently on routine assignments or projects.
  • Ability to plan, organize and multi-task to complete assignments in an efficient manner.
  • Ability to communicate professionally, both oral and written.
  • Ability to pay attention to details and perform at a high-level accuracy.
  • Ability to work independently and with a team.
  • Ability to work hours that conform to standard business operations (8:00 A.M. to 5:00 P.M.)

Why Join Bio-Techne:

  • We offer competitive salaries along with extensive medical, vision, and dental plans for you and your family starting on day one!
  • We invest in our employees’ financial futures through 401k matching and an employee stock purchase plan.
  • We help our employees develop their careers through mentorship, promotional opportunities, training and development, 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 foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.

 

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.

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

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