Product Release & QA Coordinator

FUJIFILM Holdings America Corporation; 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, seeks a Product Release Coordinator to ensure product quality by reviewing batch documentation and signing Certificates of Analysis. You will also verify Return Goods Authorizations and maintain QA final release history.

This role requires familiarity with GMP, FDA/QSR, ISO13485, and related regulations, plus proficiency with Word, Excel and document control. On-site with competitive pay and benefits.

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 QA in medical device manufacturing or equivalent.
• Proficiency in WordPerfect, MS Word, Excel, and Outlook.
• Knowledge of 21 CFR 211 cGMP, FDA QSR 820, ISO13485, and related regulations.
• Ability to read, write, and speak English.
• Strong oral and written communication skills.

Responsibilities

• Review batch documentation and maintain QA final release history.
• Create and maintain database for Certificate of Analysis.
• Review and process Return Goods Authorizations.
• Inspect labeling and storage conditions.
• Maintain the non-conforming material log and files.
• Assist in preparing controlled documents (generate DCRs).
• Support internal audits as needed.
• Assist Document Control and collaborate across departments.
• Lot folder scanning.
• Provide training as needed.

Skills

Good oral communications

English proficiency

Mathematics & chemistry

Computer skills

Education

High school diploma or equivalent

Two years of college in a science discipline

Two years QA in medical device manufacturing

Tools

WordPerfect

MS Word

Excel

Outlook

Job description

FUJIFILM Biosciences in Santa Ana, CA, seeks a Product Release Coordinator to ensure product quality by reviewing batch documentation and signing Certificates of Analysis. You will also verify Return Goods Authorizations and maintain QA final release history.

This role requires familiarity with GMP, FDA/QSR, ISO13485, and related regulations, plus proficiency with Word, Excel and document control. On-site with competitive pay and benefits.