Document Control & Labeling Specialist: QA & Compliance

FUJIFILM Biosciences; Santa Ana (CA); On-site; USD 64,000 - 79,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Life Insurance

401k

Paid Time Off

Job summary

FUJIFILM Biosciences is hiring a Document Control Labeling Specialist to compile control records for label issuance and production labeling. You will assemble batch records (DHR) and verify documents prior to lot folder assembly while maintaining label inventory.

The role requires 3–5 years of QA document control experience in医療機器 manufacturing, strong MS Word/Excel skills, and familiarity with cGMP and ISO 13485. On-site in Santa Ana, CA with competitive benefits.

Qualifications

• High school diploma or equivalent; 3–5 years QA Document Control admin exp in medical device manufacturing or equivalent.
• Experience with labeling systems and document control procedures is required.
• Proficient in MS Word, Excel, and Gmail; strong written and verbal English.
• Familiarity with regulatory standards (cGMP, ISO 13485, CFR) is preferred.

Responsibilities

• Compile and maintain control records for label issuance and production labeling.
• Assemble lot folders and manage work schedules for manufacturing departments.
• Verify documents prior to lot folder assembly and maintain label inventory.
• Support the Document Control program and related QA activities.
• Communicate effectively with cross-functional teams to ensure compliance.

Skills

Labeling Systems

MS Word

Excel

Gmail

English proficiency

Communication skills

Graphic design knowledge

Education

High school diploma or equivalent

3–5 years QA Document Control admin experience

Tools

Graphic design software

Job description

FUJIFILM Biosciences is hiring a Document Control Labeling Specialist to compile control records for label issuance and production labeling. You will assemble batch records (DHR) and verify documents prior to lot folder assembly while maintaining label inventory.

The role requires 3–5 years of QA document control experience in医療機器 manufacturing, strong MS Word/Excel skills, and familiarity with cGMP and ISO 13485. On-site in Santa Ana, CA with competitive benefits.