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QA Support Specialist

Irvine Scientific
Santa Ana, CA Full Time
POSTED ON 1/20/2025
AVAILABLE BEFORE 4/18/2025

FUJIFILM Irvine Scientific, Inc. is hiring a QA Support Specialist. The QA Support Specialist supports external and internal requests for quality information. Helps to manage change notifications, surveys, qualifications, supplier management, audit corrective actions, and management of customer support related to Quality related questions.

Responsibilities :

  • Helps customers obtain requested information (RFQ, master files, quality questions, investigations, certificates, trending, summaries, follow up, etc.)
  • Acts as customer liaison for internal inquiries and provides voice of customer
  • Coordinates customer surveys and questionnaires completion
  • Assists with supplier questionnaires and qualification
  • Assists with customer audits and follow up actions
  • Assists with change notification and supplier management
  • Assists with batch record review or other duties as needed
  • Assists with coordination of quality activities for related FISI production sites

Required Skills / Education :

  • BS / BA in Biology, Microbiology, or Chemistry preferred
  • 3-5 years of QA experience in medical device or biopharmaceutical environment
  • Must be familiar with FDA’s GMPs (QSR), ISO 13485, MDD 93 / 42, IVDD 98 / 79 / EC, Health Canada and MDR requirements
  • Ability to speak, read, and write proficiently in English
  • Good oral and written communication skills
  • Salary and Benefits :

  • For California, the base salary range for this position is $22.78 - $29.61 per hour. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).
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