Sr. Operations Quality Engineer

Par Health

Raleigh, United States
Not specified
5 years qa pharmaceutical manufacturing experience
Knowledge of ich guidelines fda ema usp ep jp
Statistical analysis tools spc doe fmea six sigma
Par Health is seeking a Sr. Operations Quality Engineer to ensure compliance with quality regulations and improve processes in a cGMP manufacturing setting. The ideal candidate will have extensive experience in quality assurance within the pharmaceutical industry, along with strong analytical and problem-solving skills

Job Summary

  • The role involves interpreting regulations and developing SOPs to ensure the delivery of high-quality products in a cGMP setting.
  • Candidates will act as a subject matter expert for validation activities and lead compliance efforts for the site.
  • The position requires utilizing statistical tools to analyze data, identify root causes, and develop corrective actions for complex problems.

Matching Summary

Match Score: 85

Par Health is seeking a Sr. Operations Quality Engineer to ensure compliance with quality regulations and improve processes in a cGMP manufacturing setting. The ideal candidate will have extensive experience in quality assurance within the pharmaceutical industry, along with strong analytical and problem-solving skills.

Skills & Requirements

Must-have

  • 5 years QA pharmaceutical manufacturing experience
  • Knowledge of ICH Guidelines FDA EMA USP EP JP
  • Statistical analysis tools SPC DOE FMEA Six Sigma
  • Experience with cGMP manufacturing environment
  • Root cause analysis and CAPA project leadership

Nice-to-have

  • CQE or CQA certification preferred
  • Six Sigma Tools or certification knowledge
  • Strong facilitation and presentation skills
  • Experience leading continuous improvement kaizen activities
  • Self-motivated ability to work with minimum supervision

Key Requirements

  • B.S. degree in Engineering or Science
  • Minimum 5 years QA/pharmaceutical manufacturing experience
  • CQE or CQA certification (preferred)

Work Rights

Not specified

Tailored Resume

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