QA Final Product Release Coordinator
Quality Assurance | Santa Ana | CA
We are hiring for a QA Final Product Release Coordinator. The Final Product Release Coordinator will ensure quality of products by performing reviews of batch folder documentation in order to release products. The person in this role will also create and sign off on all Certificates of Analysis. The Release Coordinator will also be responsible for return goods authorization product verification. In addition, this person will ensure quality is present through a view of all documentation, labeling, and storage conditions of in-process and final product in accordance with Standard Operating Procedures. The Final Product Release Coordinator is also responsible for verifying compliance with ISO13485:2003, QSR and Canadian Device Regulations.
- Review and verify all documentation in the batch record and maintain database for the QA Final Release History
- Create and maintain 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)
- Review and improve processes as needed (provide training as needed)
- Maintain Device History Records files and database
- Perform internal audits as needed
- Assist Document Control department as needed
- Collaborate with other departments to meet customer requests
- Lot folder scanning
- High school diploma or equivalent required, with basic understanding of mathematics and chemistry necessary; Two years of college study in a scientific discipline preferred
- A minimum of two (2) years of Quality Assurance in medical device manufacturer or equivalent
- Proficiency in current versions of WordPerfect, MS Word, Excel, Outlook
- Knowledge of current industry regulations, i.e. detailed understanding of 21CFR211-cGMP, FDA QSR 820, ISO13485:2003, Canadian Medical Device Regulations and inspection and auditing guidelines
Principals only. No recruiters please.
FUJIFILM Irvine Scientific is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.