Quality Assurance Associate
Orange County, CA
Contract to Hire
Overview
The Quality Assurance Associate supports the release of manufactured products by verifying that production activities and documentation meet established quality standards and regulatory expectations. This role focuses on reviewing manufacturing and packaging records, confirming data accuracy, and ensuring adherence to Good Manufacturing Practices (GMP), documentation standards, and data integrity requirements. The position works closely with production and quality teams to help maintain compliance and readiness for inspections.
Key Responsibilities
- Review manufacturing, filling, inspection, and packaging documentation to confirm activities were completed according to approved procedures and quality requirements.
- Examine batch records for completeness, accuracy, and compliance with regulatory and internal standards.
- Verify and organize production documentation to ensure proper recordkeeping and traceability.
- Prepare and distribute logbooks and documentation tools for departments such as Manufacturing, Quality, and Laboratory Operations.
- Compile completed batch documentation and supporting records for archiving, scanning, and retention in accordance with company procedures.
- Ensure records and database entries are accurate, complete, and properly maintained within documentation systems.
- Provide quality and documentation support as needed to meet operational goals.
Qualifications
- Associate or Bachelor’s degree in a life science, engineering, or related field, or equivalent hands-on experience in a regulated environment.
- Entry-level to early-career experience in pharmaceutical, biotechnology, or medical device manufacturing is preferred.
- Familiarity with sterile or controlled manufacturing environments is beneficial.
- Strong attention to detail, organization, and communication skills, with the ability to manage documentation effectively in a compliance-driven setting.
...