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Quality Assurance Specialist

4 weeks ago

Santa Ana, California, United States FISI - FUJIFILM Irvine Scientific Full time
Job Summary

FISI - FUJIFILM Irvine Scientific is seeking a Quality Assurance Specialist to join our team. The successful candidate will be responsible for coordinating and scheduling customer and regulatory inspections and audits, as well as assisting with audit and observation closure.

The ideal candidate will have a strong understanding of current industry regulations, including cGMP, FDA QSR 820, and IS013485. They will also possess excellent communication and collaboration skills, as well as the ability to speak, read, and write proficiently in English.

Key Responsibilities:

  • Coordinate preparation for and assist in hosting customer and regulatory audits
  • Manage audit calendar and input audit report and findings into MasterControl or other tracking systems
  • Collaborate with other departments to meet audit response proposed timelines and observation closures
  • Respond to customers' requests for information and provide voice of customer
  • Assist with material qualifications, change assessment, change notification, and supplier management

Requirements:

  • High school diploma or equivalent; two years of college in a science discipline preferred
  • 2-3 years of QA experience in medical device or biopharmaceutical environment
  • Proficiency in current versions of MS Word, Excel, Outlook
  • Excellent communication and collaboration skills
  • Auditing experience highly preferred

Benefits:

  • $ per hour depending on experience
  • Medical, Dental, Vision
  • Life Insurance
  • 401k
  • Paid Time Off

FISI - FUJIFILM Irvine Scientific is an equal opportunity employer and welcomes applications from diverse candidates.