Sr Quality Assurance Specialist

Evonik Corporation

Birmingham, AL, United States
Hybrid
Quality management system documentation review
Risk management
Statistical analysis
This position is responsible for providing quality and technical support to the production team providing oversight to manufacturing rooms and laboratories by reviewing and approving data and all other Quality Management System documentation

Job Summary

  • This position is responsible for providing quality and technical support to the production team providing oversight to manufacturing rooms and laboratories by reviewing and approving data and all other Quality Management System documentation.
  • At Evonik, you have the chance to explore, thrive, and grow alongside 33,000 colleagues.
  • The Evonik Group adopts an Equal Employment Opportunity (EEO) approach.

Matching Summary

This position is responsible for providing quality and technical support to the production team providing oversight to manufacturing rooms and laboratories by reviewing and approving data and all other Quality Management System documentation.

Skills & Requirements

Must-have

  • Quality Management System documentation review
  • risk management
  • statistical analysis
  • deviation and CAPA investigations
  • root cause analysis
  • product quality and system improvements
  • regulatory agency inspections

Nice-to-have

  • hybrid and flexible working environments
  • fresh perspective
  • develop your strengths
  • break out your mold
  • interpersonal skills

Key Requirements

  • Bachelor of Science degree
  • Minimum eight years' experience in pharmaceutical or medical device manufacturing
  • Minimum five years' experience in pharmaceutical or medical device Quality Assurance
  • Proficient computer skills
  • Knowledge of FDA’s cGMP and/or QSR quality system requirements
  • Applied statistics experience
  • Validation experience
  • Experience in Regulatory Agency inspections
  • Experience in aseptic techniques and manufacturing

Work Rights

Not specified

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