Sr Quality Assurance Specialist

Jenacell GmbH

Birmingham, AL, United States
Hybrid
Quality management system documentation review
Risk management and statistical analysis
Product and process documentation approval
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.
  • The position utilizes risk management, quality planning and statistical analysis to complete assigned tasks.
  • At Evonik, you have the chance to explore, thrive, and grow alongside 33,000 colleagues.

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 and statistical analysis
  • Product and process documentation approval
  • Deviation and CAPA investigation support
  • Root cause analysis of quality deficits
  • Real-time production floor QA oversight

Nice-to-have

  • Shape innovative solutions
  • Hybrid and flexible working environments
  • Develop your strengths
  • Fresh perspective
  • High-quality development programs

Key Requirements

  • Bachelor of Science degree
  • Minimum eight years' experience in pharmaceutical or medical device manufacturing
  • Minimum five years' experience in Quality Assurance role
  • Knowledge of FDA's cGMP and/or QSR
  • Validation experience
  • Experience in Regulatory Agency inspections

Work Rights

Not specified

Tailored Resume

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