QA Release Coordinator: Quality, Docs & Compliance

FUJIFILM Biotechnologies; 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 seeking a Product Release Coordinator to ensure product quality by reviewing batch folder documentation and signing off on Certificate of Analysis. The role also handles return goods verification, labeling inspection, and maintaining controlled documents and release histories, collaborating across departments to meet customer requests.

Must have knowledge of 21 CFR 211/ cGMP, ISO 13485 and related regulations; strong attention to detail, computer skills

Qualifications

• High school diploma or equivalent required.
• Two years of college in a science discipline preferred.
• Minimum two years of QA experience in medical device manufacturing preferred.
• Proficiency in WordPerfect, MS Word, Excel and Outlook.
• Strong computer skills and knowledge of industry regulations.
• Ability to read, write and speak English clearly.
• Good oral and written communication skills.

Responsibilities

• Review and verify batch documentation and maintain QA release history.
• Create and sign off Certificate of Analysis.
• Review and process Return Goods Authorizations.
• Inspect labeling and storage conditions of product.
• Maintain non-conforming material log, files and database.
• Assist in preparing controlled documents and training as needed.
• Support device history records and internal audits.
• Collaborate with other departments to meet customer requests.
• Lot folder scanning.

Skills

English language proficiency

Oral communication

Education

High school diploma or equivalent

Two years of college in science (preferred)

Two years QA in medical device manufacturing (preferred)

Tools

WordPerfect

MS Word

Excel

Outlook

Job description

FUJIFILM Biosciences in Santa Ana, CA is seeking a Product Release Coordinator to ensure product quality by reviewing batch folder documentation and signing off on Certificate of Analysis. The role also handles return goods verification, labeling inspection, and maintaining controlled documents and release histories, collaborating across departments to meet customer requests.

Must have knowledge of 21 CFR 211/ cGMP, ISO 13485 and related regulations; strong attention to detail, computer skills