QA Auditor

Company: FUJIFILM Holdings America Corporation
Location: Santa Ana
Posted on: March 28, 2025

Job Description:

Position OverviewWe are hiring a QA Auditor. The QA Auditor performs and assists with supplier, distributor, and internal audits. They will be responsible for the coordination and completion of supplier qualifications, re-evaluation and maintaining the electronic supplier files.Company OverviewFUJIFILM Irvine Scientific, Inc. is a global leader in the innovation and manufacture of cell culture solutions for Life Science and Medical markets, providing products and services that assist customers in advancing healthcare initiatives. Working across discovery research, cell and gene therapy, reproductive medicine and cytogenetics, as well as the large-scale production of biotherapeutics and vaccines, the Company is trusted by researchers, manufacturers, and clinicians worldwide. For over 50 years, FUJIFILM Irvine Scientific's Mission has been to empower all who bring medicines and treatments to life with unmatched quality and responsiveness in its products and custom solutions, providing customers with the vital resources needed to enrich human lives through innovative, accessible therapies. The Company's facilities adhere to both ISO and FDA regulations, with manufacturing facilities that follow cGMP guidelines in the USA, Japan, and the Netherlands, and a media optimization center in China. All sites prioritize strategies that adhere to the FUJIFILM Sustainability Value Plan 2030 for sustainable growth. FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation reporting to FUJIFILM Holdings Corporation.Job DescriptionResponsibilities

• Plan and perform internal, distributor and supplier audits (on-site, paper, and remote)
• Coordinate with internal personnel and suppliers to schedule, execute and follow up with audit observations
• Collaborate with other departments to meet the audit response proposed timelines
• Perform supplier qualification and supplier re-evaluations
• Maintain audit documentation and completion of audit observations
• Maintain supplier files including, but not limited to qualification, re-evaluation, audit reports, and current ISO certification or applicable accreditations
• Assist with regulatory audits as needed
• Routine review of supplier activity for potential inactivation, future audits, and other actions such as SCARS initiation, or "For Cause Audit"
• Assist with the development or maintenance of annual audit schedules
• Travel domestic and international as needed for supplier auditingRequired Skills/Education
  • BS/BA in Biology, Microbiology, or Chemistry required or equivalent science degree
  • 2-3 years of QA experience in medical device or biopharmaceutical environment
  • Proficiency in current versions of MS Word, Excel
  • Excellent communication and collaboration skills
  • Auditing experience highly preferred
  • Current industry regulations, i.e., detailed understanding of 21 CFR 211-cGMP, FDA QSR 820, ISO 13485, Canadian Medical Device Regulations, Brazil, EU and inspection and auditing
  • Excellent computer skills including MS Word, Excel, Access, PowerPoint, Outlook, ERP/MRP system, Document control programs
  • Ability to speak, read, and write proficiently in English
  • Good oral and written communication skills
  • Able to travel 20-30% of the time domestically and internationallySalary and Benefits:
    • For California, the base salary range for this position is $79,954 - $104,236. 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 OffEEO InformationFujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.ADA InformationIf you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (fisihr@fujifilm.com).
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Keywords: FUJIFILM Holdings America Corporation, Santa Ana , QA Auditor, Accounting, Auditing , Santa Ana, California