We are hiring a QA Support Specialist. The QA Support Specialist will support external and internal requests for quality information. They will also help manage change notifications, surveys, qualifications, supplier management, audit corrective actions, and management of customer support related to Quality related questions.

At FUJIFILM Irvine Scientific (dba FUJIFILM Biosciences), we turn curiosity into breakthroughs that advance the field of life sciences. By offering a comprehensive portfolio of products and services in cell culture media, discovery research reagents, recombinant growth factors and proteins, fine chemicals, and critical assay materials, we partner with the brightest minds in biotech and pharma to tackle the world’s biggest health challenges.

Imagine being part of a team that enables life-changing discoveries like new vaccines, therapies, and advancements in regenerative medicine. Our culture fosters curiosity, collaboration, and innovation, and we pride ourselves on delivering unparalleled quality and service to our partners. If you’re ready to make an impact, your future belongs with us at FUJIFILM Irvine Scientific (dba FUJIFILM Biosciences).

Our headquarters in Santa Ana, California, is surrounded by world-class schools, lush parks, and scenic beaches like Laguna and Huntington, making it an ideal place to live, work, and explore. With additional campuses across the US, Europe, China, and Japan, we offer opportunities to make a difference worldwide.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

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 $30.21 - $39.30 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

*#LI-onsite       

Fujifilm 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.

If 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).