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Contract research and manufacturing company in suburban Cleveland is searching for a Quality Assurance Manager provide quality oversight and support to the site’s technical operations group for the manufacture and characterization of non-clinical, clinical and commercial products in compliance with GMP and GLP guidelines.
 
Requirements for QA Manager:
 
  • Bachelor’s degree in a technical or scientific discipline
  • 7+ years’ experience in the pharmaceutical / biotech industry
  • 5+ years’ experience in Quality Assurance supporting manufacturing and characterization of small molecule drug substance for clinical and commercial use in a contract environment.
  • Working knowledge and technical understanding of the manufacture and testing of small molecule drug substance and drug product
  • Knowledge of GMP and GLP principles with respect to FDA and EMA regulations and guidelines
  • Knowledge of drug development process
  • Experience in deviation investigations, root cause analysis, risk assessment and developing corrective action plans
  • Experience in data integrity / 21CFR Part 11 Compliance
  • Experience is process validation, analytical method validation and equipment qualification
  • Excellent communication and documentation skills
  • Experience managing multiple priorities and quality assurance staff
 
 
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