QA Support Specialist

Job Description

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, 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 provide voice of customer
• Coordinates customer surveys and questionnaires completion
• Assist with supplier questionnaires and qualification
• Assist with customer audits and follow up actions
• Assist with change notification and supplier management
• Assist with batch record review or other duties as needed
• Assist 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
• Excellent computer skills including MS Word, Excel, PowerPoint
• 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.).
• Medical, Dental, Vision
• Life Insurance
• 401k
• Paid Time Off