Quality Specialist

CSL Ltd

Americas, GA, United States
Not specified
Monitoring plasma center processes
Ensuring compliance with fda regulations
Conducting internal and external audits
CSL Ltd is seeking a Quality Specialist for their plasma donation center in the Americas, GA. The role focuses on ensuring compliance with quality standards and regulatory requirements while supporting training and quality improvement initiatives

Job Summary

  • This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures and all applicable local, state, federal requirements.
  • The role involves performing final QA review and release for all shipments, initiating investigations into regulatory deficiencies, and determining the effectiveness of corrective actions.
  • CSL Plasma operates one of the world's largest and most sophisticated plasma donation networks, using collected plasma to manufacture lifesaving therapies for people in over 100 countries.

Matching Summary

Match Score: 85

CSL Ltd is seeking a Quality Specialist for their plasma donation center in the Americas, GA. The role focuses on ensuring compliance with quality standards and regulatory requirements while supporting training and quality improvement initiatives.

Skills & Requirements

Must-have

  • monitoring plasma center processes
  • ensuring compliance with FDA regulations
  • conducting internal and external audits
  • managing training documentation and LMS
  • investigating regulatory deficiencies
  • initiating corrective action plans

Nice-to-have

  • strong critical reasoning skills
  • experience in regulated environments
  • ability to handle shifting priorities
  • customer service orientation
  • knowledge of CLIA/COLA requirements

Key Requirements

  • High school diploma or equivalent required
  • Minimum 1-year leadership experience or regulated environment experience
  • Associate or Bachelor's degree preferred in business or biological sciences

Work Rights

Not specified

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