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Document Control Labeling Spec

FUJIFILM Holdings America Corporation, Santa Ana, CA, United States


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: 10:00 am - 6:30 pm

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 Weber 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 $35 - $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

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 (flbi@fujifilm.com).

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