We are hiring a Product Release Coordinator. The Product Release Coordinator will be responsible for ensuring quality of product by performing reviews of batch folder documentation in order to release product. They will create and sign off all Certificate of Analysis and be responsible for returned goods authorization product verification.

At FUJIFILM Irvine Scientific, 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.

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 

• Creates and maintains database for Certificate of Analysis
• Inspect labeling and storage conditions of product
• Assist in the preparation of all controlled documents (generating DCRs as needed)
• Reviews and improves processes as needed (provides training as needed)
• Maintains Device History Records files and database
• Assist Document Control department as needed
• Collaborates with other departments to meet customer requests
• Lot folder scanning

Required Skills/Education 

• High school diploma or equivalent; basic understanding of mathematics and chemistry necessary
• Two years of college in a science discipline is preferred
• A minimum of two (2) years of Quality Assurance in medical device manufacturer or equivalent
• Proficiency in current versions of WordPerfect, MS Word, Excel, Outlook and an MRP system
• Computer skills
• Current industry regulations, i.e. Detailed understanding of 21CFR211-cGMP, FDA QSR 820, ISO13485:2003, Canadian Medical Device Regulations and inspection and auditing guidelines
• Ability to speak, read, and write English
• Good Oral and communication skills

Salary and Benefits:

• For California, the base hourly range for this position is $24.93 - $32.26 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).