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.

FUJIFILM 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. 

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).