Labeling & Document Control Specialist (DHR/QA)

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

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