Kurosbiosciencesinc

Kurosbiosciencesinc

US Operator

Alpharetta, GA · Full-time

Sponsorship not specifiedDetected 1 day ago
GMPFDA RegulatoryMedical Devices

About the role

  • This role is critical to ensuring product quality, traceability, and compliance throughout the production process.
  • This is a full-time, hourly, on-site position: Monday-Friday from 7:30 AM to 4 PM.

Responsibilities

  • Support the commencement of our new manufacturing facility in Alpharetta, Georgia.
  • Support the commencement of our new manufacturing facility in Alpharetta, Georgia. This includes but not limited to:
  • Support the Execution of our IQ/OQ/PQ validation process prior to go-live of our new manufacturing
  • Support the development and continuous improvement of our training program.
  • Perform manual and semi-automated assembly of our Magnetos product family in an ISO Class 8 cleanroom and controlled lab environment.
  • Operate and maintain cleanroom equipment and tools (e.g., graduated cylinders, vibration tables, scales, vacuum sealers, ovens, dispensers).
  • Maintain cleanroom gowning protocols and adhere strictly to contamination control and hygiene standards.
  • Support cleaning, calibration, and routine maintenance of equipment and cleanroom areas.

Requirements

  • Bachelor's degree in Biology, Chemistry Engineering, Biology, or related field required.
  • Education:
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Skills

  • Traveling to our Bilthoven, Netherlands manufacturing location for on-the-job training and knowledge transfer.
  • Follow detailed work instructions, standard operating procedures (SOPs), and batch records accurately.
  • Perform in-process inspections to verify quality specifications.
  • Handle sterile or non-sterile packaging and labeling of finished products, ensuring lot control and traceability.
  • Accurately complete production documentation, including batch records, in compliance with FDA 21 CFR Part 820 and ISO 13485.
  • Report deviations, non-conformances, or equipment malfunctions to quality personnel promptly.
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