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Quality Assurance Specialist II

2 months ago

Fargo, North Dakota, United States Aldevron Full time

About Aldevron

At Aldevron, we are dedicated to advancing science and improving human health through innovative products and services. Our team of experts shares a common goal of combining best-in-class products and services with the ideal operating environment to drive vital new discoveries worldwide.

We believe that our people are our most valuable asset, and we strive to create a workplace that values diversity, inclusivity, and collaboration. Whether you're just starting your career or looking to take the next step, we welcome talented individuals from all backgrounds and experiences.

About the Role

This position is part of the Operational Quality Assurance department, located in Fargo, ND. As a Quality Assurance Specialist II, you will be responsible for providing quality assurance services to ensure the integrity of products received and shipped out, services provided to clients, and compliance with government regulations and industry standards.

Key Responsibilities

  • Execute label generation to ensure identity and traceability of final material
  • Review GMP and GMP-S Batch Record Documentation
  • Complete review of Packaging generated secondary labels prior to packaging event
  • In-process release activities (i.e. suite review)
  • Review solution preparation material and documentation associated with material
  • Maintain control over materials in accordance with quarantine and release procedures
  • Create and maintain spreadsheets and databases to ensure consistent quality metric tracking and communication between departments

Requirements

  • 1+ years of experience in a Quality, Auditing or Inspecting role
  • Experience working in a regulated or GMP compliant environment
  • High School Diploma or equivalent GED required

Preferred Qualifications

  • Bachelor of Science; life science related field, preferred or equivalent experience
  • Dynamic 365 experience
  • LIMS or similar lab management systems

Work Schedule

This is a second shift position, working Monday - Friday, 3:00pm - 12:00 midnight.