Quality Assurance Analyst

Evonik Industries AG

Lafayette, IN, United States
On-site
Production issue resolution
Quality event assessment
Deviation and change control review
Evonik Industries AG is seeking a Quality Assurance Analyst for their Lafayette, IN location. The role involves ensuring compliance with GMP standards, managing quality events, and supporting production processes, requiring a strong background in quality systems and communication skills

Job Summary

  • Provide first point of contact for production issues and compliance questions, and approve initial assessments for all quality events.
  • Collaborate with Operations to review and approve minor deviations and change controls, and disposition all GMP API and final intermediate batches.
  • Ensure adherence to site cleaning program, approve Master Production Records, and contribute to continuous improvement via project teams.

Matching Summary

Match Score: 85

Evonik Industries AG is seeking a Quality Assurance Analyst for their Lafayette, IN location. The role involves ensuring compliance with GMP standards, managing quality events, and supporting production processes, requiring a strong background in quality systems and communication skills.

Skills & Requirements

Must-have

  • production issue resolution
  • quality event assessment
  • deviation and change control review
  • batch disposition
  • cGMP and ISO 9001 compliance

Nice-to-have

  • continuous improvement contribution
  • customer audit support
  • mentorship of junior staff

Key Requirements

  • BS in chemistry, engineering, science, or equivalent experience
  • 3-5 years industrial experience in a GMP environment
  • Experience with quality systems (change controls, deviation investigations, validation documentation)
  • Willing to work nights and weekends as needed for 24/7 coverage

Work Rights

Not specified

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