Quality Engineer - OQSIE
Irvine, CA
About the Job
Provides Quality Assurance support for Manufacturing, Packaging, Supply Chain, and Quality Control Laboratories. The position requires QA review/approval of investigation reports, change controls, Maintenance work orders, Standard Operating Procedures, Process Validation Protocols/Reports, new and existing methods/procedures, validation/transfer protocols, investigation documentation, and process/facility change control documents. Leads teams using trend and investigational data to identify potential trends and mitigate through process improvements and failure reduction activities. The QA Engineer must perform independently to identify failure modes and related process improvements, facilitating teams and working to implement required changes.
Qualifications
- Requires a Bachelor's Degree in Science or Engineering.
- Requires a minimum of 10 years of quality assurance experience in the Pharmaceutical or related industry, or equivalent.
- Requires a minimum of 5 years of quality engineering experience in Aseptic manufacturing environments.
- Experience writing, conducting and/or approving deviations, investigations, and CAPAs (highly preferred).
- Experience of applicable technologies, quality systems, validation, investigations.