Quality Assurance Specialist

5 days ago


Devens, Massachusetts, United States Bio-Techne Full time
About Us

Bio-Techne is a leading developer and manufacturer of high-quality reagents, instruments, custom manufacturing, and testing services for Life Science and Clinical Diagnostics. Our family of brands creates a unique portfolio of products and services that empower researchers to achieve reproducible and consistent results.

Job Description:

We are seeking a Quality Assurance Specialist to join our team. The ideal candidate will have a strong background in quality assurance, regulatory compliance, and manufacturing processes. You will be responsible for ensuring that all products meet the highest quality standards and comply with relevant regulations.

Key Responsibilities:

  • Reviewing and approving validations, protocols, SOPs, and technical reports
  • Ensuring systems, utilities, and processes comply with FDA and industry standards
  • Responding to and resolving customer complaints about products
  • Coordinating complaint investigations with assistance of members of the CAPA/Complaint team
  • Generating and sharing Complaint Response

The ideal candidate will have a Bachelor's degree in Engineering or a related field and 3-5 years of experience working on the manufacturing and production of In Vitro Diagnostics (IVDs), Medical Devices, or Pharmaceutical products. Strong communication skills, both verbal and written, and a working knowledge of analytical and process equipment, quality control systems, and statistical software are essential.

Salary Range: $90,000 - $140,000 per year



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