Product Release & QA Coordinator

FUJIFILM Biosciences; Santa Ana (CA); On-site; USD 35,000 - 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, CA is hiring a Product Release Coordinator responsible for ensuring product quality by reviewing batch folder documentation and releasing products after sign-off. You will create and sign off Certificates of Analysis, manage Return Goods Authorizations, and maintain compliant device history records while collaborating with QA and regulatory teams.

The ideal candidate has attention to detail, familiarity with 21 CFR parts and ISO quality standards, and

Qualifications

• Must have strong attention to detail and ability to maintain accurate documentation.
• Experience with QA in medical device industry or equivalent preferred.
• Familiarity with regulatory requirements (FDA, ISO) and batch documentation practices.

Responsibilities

• Review batch records and maintain QA Final Release History database.
• Create and maintain Certificate of Analysis records.
• Process Return Goods Authorizations and inspect labeling/storage conditions.
• Maintain non-conforming material logs and controlled document systems.
• Assist in preparing controlled documents and training as needed.
• Collaborate with other departments to fulfill customer requests.
• Assist Device History Records files and internal audits as required.
• Support Document Control and process improvements.

Skills

Attention to detail

Quality mindset

Communication skills

Problem solving

Education

High school diploma or equivalent

Two years of college in a science discipline

Two years of Quality Assurance in medical device manufacturer or equivalent

Tools

WordPerfect

MS Word

Excel

Outlook

Job description

FUJIFILM Biosciences in Santa Ana, CA is hiring a Product Release Coordinator responsible for ensuring product quality by reviewing batch folder documentation and releasing products after sign-off. You will create and sign off Certificates of Analysis, manage Return Goods Authorizations, and maintain compliant device history records while collaborating with QA and regulatory teams.

The ideal candidate has attention to detail, familiarity with 21 CFR parts and ISO quality standards, and