QA Release Coordinator – Life Sciences

FUJIFILM Holdings America Corporation; Dyer (CA); On-site; USD 36,000 - 40,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Life Insurance

401k

Paid Time Off

Job summary

FUJIFILM Biosciences in Santa Ana, California, seeks a Product Release Coordinator to ensure product quality by reviewing batch records, signing off Certificates of Analysis, and handling return goods verification. The role supports batch release, labeling inspection, and document control in a regulated medical device setting.

The position requires a high school diploma, science coursework, and 2+ years QA experience in medical devices. On-site work with competitive benefits is provided.

Qualifications

• High school diploma or equivalent.
• Basic understanding of mathematics and chemistry.
• Two years of college in a science discipline preferred.
• Minimum of two years of Quality Assurance in medical device manufacturing or equivalent.
• Proficiency in WordPerfect, MS Word, Excel, Outlook.
• Knowledge of current industry regulations (21CFR211-cGMP, FDA QSR 820, ISO13485:2003, Canadian Medical Device Regulations).
• English reading/writing and good oral communication.

Responsibilities

• Review and verify batch documentation and maintain the QA Final Release History.
• Create and maintain database for Certificate of Analysis.
• Review and process Return Goods Authorizations.
• Inspect labeling and storage conditions of product.
• Maintain the non-conforming material log, files and database.
• Assist in the preparation of controlled documents (generating DCRs as needed).
• Review and improve processes and provide training as needed.
• Maintain Device History Records files and database.
• Perform internal audits as needed.
• Assist Document Control department as needed.
• Collaborate with other departments to meet customer requests.
• Lot folder scanning.

Skills

Math & Chemistry basics

MS Word

Excel

Outlook

Communication skills

English proficiency

Education

High school diploma or equivalent

Two years of college in a science discipline

Two years QA in medical device manufacturing or equivalent

Tools

WordPerfect

MS Word

Excel

Outlook

Job description

FUJIFILM Biosciences in Santa Ana, California, seeks a Product Release Coordinator to ensure product quality by reviewing batch records, signing off Certificates of Analysis, and handling return goods verification. The role supports batch release, labeling inspection, and document control in a regulated medical device setting.

The position requires a high school diploma, science coursework, and 2+ years QA experience in medical devices. On-site work with competitive benefits is provided.