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Job Details


Quality Assurance (QA) Auditor (Full Time)

Location: 44077 Ohio Country: United States of America

Essential Job Functions:

  • Ensure manufacturing and laboratory operations are performed in accordance with cGMPs under ICH Q7 and 21CFR210/211
  • Conduct in-process inspections of manufacturing and laboratory operations
  • Conduct audits of protocols, Master Batch Records, Production Batch Records, in-process and release laboratory data, cleaning records, test methods, and SOPs
  • Perform internal audits of systems and processes
  • Provide assistance with vendor qualification program and other quality-based systems

Educational Requirements:

  • Bachelor's degree in relevant field or Associate's degree with 2-4 years' experience

Work Experience/Skills Requirements:

  • Knowledge of auditing techniques
  • Ability to work independently and collectively with diverse groups comprised of chemists, engineers, and technicians

Preferred Skills:

  • Experience in quality control
  • Experience with QA GMP manufacturing experience (clinical API manufacturing desired)
  • Knowledge of pharmaceutical principles, practices, and their applications

Posted Date: 02 Oct 2019 Reference: CB Company: OlonRicerca Bioscience Contact: Bernadette Armbruster