Document Control Labeling Spec

Fujifilm • Santa Ana, CA

1d • Onsite

About The Position

We are hiring a Document Control Labeling Specialist. The Document Control Labeling Specialist will compile and maintain control records relating to label issuance, print of production labels for manufacturing, assemble batch records (DHR) for all production departments and verify all documents including formulations, manufacturing protocols and Bill of Materials prior to lot folder assembly. They also will maintain label inventory, word processing of controlled documents and support the 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

Requirements

• High school diploma or equivalent.
• A minimum of three to five (3-5) years administration experience in a Quality Assurance Document Control medical device manufacturing environment or equivalent.
• Experience with Weber Labeling Systems.
• Computer skills, specifically MS Word, Excel, GMail
• Current industry regulations, e.g. cGMP, ISO 13485, Code of Federal Regulations, MDD 93/42/EEC, IVDD 98/79/EC, TGA, and Canadian Medical Device Regulation
• Ability to speak, write, and read English.
• Good oral and written communication skills

Nice To Haves

• Graphic design knowledge a plus.

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
• Support document control program.

Benefits

• Medical
• Dental
• Vision
• Life Insurance
• 401k
• Paid Time Off

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED
• Number of Employees: 501-1,000 employees