Document Control Labeling Spec

FUJIFILM Holdings America Corporation; California; On-site; USD 65,000 - 79,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401k

Paid Time Off

Life Insurance

Job summary

FUJIFILM Biosciences is hiring a Document Control Labeling Specialist to compile and maintain control records for label issuance, print production labels, and assemble batch records across departments. The role ensures documents are verified before lot folder assembly and supports the Document Control program.

The position requires a minimum of 3–5 years in QA Document Control in medical device manufacturing, with knowledge of labeling systems and regulatory requirements such as cGMP and ISO

Qualifications

• High school diploma or equivalent.
• 3–5 years admin experience in a Quality Assurance Document Control medical device manufacturing environment or equivalent.
• Experience with Labeling Systems.
• Computer skills, specifically MS Word, Excel, GMail
• Graphic design knowledge a plus.
• Current industry regulations, e.g. cGMP, ISO 13485, CFR, 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

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.

Skills

Communication skills

English fluency

Graphic design

MS Word

Excel

Gmail

Education

High school diploma or equivalent

Tools

Labeling Systems

Job description

Position Overview

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.

Shift: 5am - 1:30pm

Company Overview

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 foster 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

Job Description

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.

Required Skills/Education:

• 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 Labeling Systems.
• Computer skills, specifically MS Word, Excel, GMail
• Graphic design knowledge a plus.
• 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

Salary and Benefits:

• For California, the base salary range for this position is $31.11 - $38 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

EEO Information

Fujifilm is committedto 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.

ADA Information

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 ([e-mail]).