QA Release & Documentation Coordinator I

Merck & Co.; Santa Ana (CA); On-site; USD 53,000 - 60,000; 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 off on Certificates of Analysis. The role includes return goods verification, labeling inspection, and maintaining QA records to support compliant release.

The candidate will work with cross-functional teams, perform internal audits, and assist in controlled document preparation.

Qualifications

• Must have QA experience in medical device manufacturing or equivalent.
• Strong understanding of regulatory requirements and quality systems.
• Ability to read, write and communicate in English clearly.

Responsibilities

• Review batch records and maintain the QA Final Release History database.
• Create and maintain the Certificate of Analysis database.
• Process Return Goods Authorizations and inspect labeling and storage.
• Maintain non-conforming material logs and file databases.
• Assist in preparing controlled documents and training staff as needed.
• Support internal audits and collaborate with other departments to meet customer requests.
• Manage Device History Records and perform routine document control tasks.

Skills

Quality Assurance

Regulatory knowledge

English writing and reading

Communication skills

Attention to detail

Education

High school diploma or equivalent

Two years of college in a science discipline is preferred

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 off on Certificates of Analysis. The role includes return goods verification, labeling inspection, and maintaining QA records to support compliant release.

The candidate will work with cross-functional teams, perform internal audits, and assist in controlled document preparation.