Quality Assurance Associate I
Lumen Bioscience, Seattle, WA +1
About the job
Quality Assurance Associate I at Lumen Bioscience
Lumen Bioscience is seeking a dedicated Quality Assurance (QA) Associate I to assist with maintaining our quality management system. This essential role supports compliance activities related to cGMP, cGLP, and cGCP (cGXP) standards, ensuring high-quality documentation, thorough reviews, and operational adherence to pharmaceutical regulations. If you have a keen eye for detail, excellent organizational skills, and a commitment to quality, we encourage you to apply.
Role Description
- Documentation and Records: Perform document scanning and archival of controlled records, maintain accurate activity logs, and issue process documentation for manufacturing operations.
- Operational Support: Provide on-the-floor QA support to manufacturing operations, assisting in ensuring compliance with established cGXP processes.
- Batch Record Review: Conduct detailed reviews of batch records and related process documentation to uphold stringent quality standards.
- Compliance Walkthroughs: Regularly conduct facility and operational walkthroughs to verify compliance with the company's quality management system aligned with 21 CFR parts 210/211.