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Quality Assurance Specialist

1 week ago

Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full time
Job Summary

We are seeking a skilled Quality Assurance Specialist to join our team. The successful candidate will be responsible for ensuring the quality and compliance of our products in accordance with regulatory requirements.

Main Responsibilities:
  • Review and approve documentation, including Standard Operating Procedures, Batch Production Records, and Commissioning, qualification and validation protocols and reports.
  • Draft and review internal Quality policies, procedures, and reports.
  • Perform inspection of final product containers and review executed process records and data.
  • Conduct Quality audits to ensure adherence to national and international standards and regulations.
  • Identify opportunities for process and Quality System improvements.
Requirements:
  • High school or equivalent and 8+ years' experience in Pharmaceutical or other regulated Industry.
  • Associates Degree and 5+ years' experience in Pharmaceutical or other regulated Industry.
  • Bachelor's degree and 3+ years' experience in Pharmaceutical or other regulated Industry.
  • Master's Degree and 1+ years' experience in Pharmaceutical or other regulated Industry.
  • Certified Quality Auditor preferred.