Quality Assurance Assistant (Contract)
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Costa Mesa, CA
We’re partnering with a biopharmaceutical organization based in Costa Mesa that provides specialized analytical testing and manufacturing support services to the life sciences industry. They are seeking a Quality Assurance Assistant to join their team on a contracting basis, supporting their Quality Management Systems (QMS) team and ensuring compliance with regulatory standards. This role is offered on a contracting basis - as a w2 contract worker you are eligible to a benefits package including health/dental/vision/life insurance, a 401k vehicle and more.
About the Role
The QA Assistant will work within the Quality Management Systems (QMS) team to support document control, administrative functions, and system maintenance activities. The position plays a key role in ensuring data integrity, compliance with regulatory requirements, and adherence to current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
Key Responsibilities
- Process, format, and route controlled documents for approval
- Maintain logs, archives, and quality records across electronic and paper systems
- Assign and issue document numbers for reports and quality records (e.g., deviations, CAPAs, change controls, and protocols)
- Maintain and update tracking logs for key quality processes and review boards
- Issue and file controlled copies of documents, forms, and production records
- Provide onboarding support by distributing training materials and maintaining training documentation
- Manage SOP lifecycle activities, ensuring updates and retirements follow procedural requirements
Please apply with an updated copy of your resume to be considered.
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