Quality Release & Documentation Coordinator

Merck & Co.; 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 documentation and signing off on Certificates of Analysis, and by handling Return Goods Authorizations.

The role requires QA experience in medical device manufacturing or equivalent, familiarity with 21 CFR 211-cGMP, FDA QSR 820, ISO13485:2003, and strong English communication skills. On-site with comprehensive benefits and competitive hourly pay.

Qualifications

• High school diploma or equivalent.
• Basic understanding of mathematics and chemistry necessary.
• Two years of college in a science discipline is preferred.
• A minimum of two (2) years of Quality Assurance in medical device manufacturer or equivalent.
• Proficiency in WordPerfect, MS Word, Excel, Outlook
• Current industry regulations, i.e. Detailed understanding of: 21CFR211-cGMP, FDA QSR 820, ISO13485:2003, Canadian Medical Device Regulations and inspection and auditing guidelines.
• Ability to speak, read, and write English.
• Good Oral and communication skills.

Responsibilities

• Review and verify all documentation in the batch record and maintain database for the QA Final Release History.
• Creates and maintains database for Certificate of Analysis
• Review and process Return Good Authorizations
• Inspect labeling and storage conditions of product
• Maintain the non-conforming material log, files and database
• Assist in the preparation of all controlled documents (generating DCRs as needed)
• Reviews and improves processes as needed (provides training as needed)
• Maintains Device History Records files and database
• Performs internal audits as needed
• Assist Document Control department as needed
• Collaborates with other departments to meet customer requests
• Lot folder scanning

Skills

English proficiency

Oral communication

Regulatory knowledge

QA experience

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, CA is seeking a Product Release Coordinator to ensure product quality by reviewing batch documentation and signing off on Certificates of Analysis, and by handling Return Goods Authorizations.

The role requires QA experience in medical device manufacturing or equivalent, familiarity with 21 CFR 211-cGMP, FDA QSR 820, ISO13485:2003, and strong English communication skills. On-site with comprehensive benefits and competitive hourly pay.