QA Technician, Product Disposition

Thermo Fisher Scientific Lenexa, KS

About the Job

The QA Specialist will review batch records, identify issues, resolve or escalate issues, and release product for sale as part of the quality assessment of product. The QA Technician requires excellent attention to detail and organizational skills to ensure timely and accurate evaluation of documentation.

Key Responsibilities:

  • Review production batch documentation for compliance with cGMP good documentation requirements.
  • Communicate effectively and coordinate tasks with Manufacturing and Quality Control to ensure timely release of products.
  • Process 100% inspection rework activities and stock adjustments.
  • Track and trend functional metrics.
  • Support Regulatory and Customer Audits.
  • Support continuous improvement activities and participate in lean activities.

Minimum Requirements:

  • High School Diploma or equivalent.
  • Working knowledge of various computer software programs such as Excel.

Preferred Requirements:

  • 1+ years of experience in QA, QC, or manufacturing within a regulated environment such as medical device, pharmaceutical, or food manufacturing.
  • Background in Medical device, cGMP, or ISO certified environment.
  • Data entry skills and familiarity with inventory management systems such as SAP.
  • Demonstrated ability to work effectively as a member of a cross-functional team.