Position Description

We are hiring a Sr Labeling Specialist. The Sr Labeling Specialist will compile and maintain control records relating to label issuance, print production labels for manufacturing and assemble batch records (DHR) for all production departments. They will also verify all documents prior to lot folder assembly, maintain label inventory, and support Document Control program.

At 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 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:

• Compile and maintain control records relating to label issuance.
• Printing production labels for manufacturing (managing work schedules)
• Assembly of Lot Folders for all departments (managing work schedules)
• Verification of all documents prior to lot folder assembly
• Maintain inventory of all label and ribbon stocks
• Creation and revision of customer specific label designs and stocks
• Manage the creation and qualification of new label stocks
• Support document control program.

Required Skills/Education:

• High school diploma or equivalent. High school diploma or equivalent.
• At least six (6) years’ relevant experience in a quality function within medical device or regulated industry.
• Experience with Weber Labeling Systems.
• Computer skills, specifically MS Word, Excel, Outlook
• Graphic design knowledge a plus.
• Current industry regulations, i.e. cGMP, ISO 13485, Code of Federal Regulations, EU Medical Device Regulation 2017/745, TGA, & Canadian Medical Device Regulation.
• Ability to speak, write and read English.
• Good oral and written communication skills.

Salary and Benefits:

• For California, the base salary range for this position is $36.66 - $47.80 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 (flbi@fujifilm.com).