QA Associate I - cGXP Compliance & Documentation

Lumen Bioscience, Inc.; Seattle (WA); On-site; USD 65,000 - 70,000; Full time

Benefits offered by this job

Health/dental/vision premiums covered

401k match

Stock bonuses

Generous PTO and wellness programs

Transit subsidies

Job summary

Lumen Bioscience is seeking a dedicated Quality Assurance (QA) Associate I to help maintain our quality management system in a cGXP regulated environment. You will support on-the-floor QA for manufacturing, review batch records, and assist with investigations and audits to ensure regulatory compliance.

The role emphasizes documentation integrity, data accuracy, and collaboration with QA leadership to uphold high quality standards in biotech operations.

Qualifications

• Associate's degree in a relevant scientific field or 1 year of regulated cGXP experience.
• Familiar with cGMP, ISO 9001, and ICH requirements for document control and quality records.
• Proficient in Word, Excel, and SharePoint.
• Strong organizational, detail-oriented, and communication skills.

Responsibilities

• Maintain documentation through scanning, archiving, and record-keeping.
• Issue and review process documentation for manufacturing schedules.
• Provide on-the-floor QA support for manufacturing compliance.
• Perform facility walkthroughs to verify adherence to regulatory requirements.
• Assist investigations and management of deviations, CAPAs, and quality events.
• Support audits, validation, qualification, and verification activities.

Skills

Attention to detail

Multitasking

Communication

Adaptability

Quality-focused

Education

Associate's degree or 1 year cGXP experience

Tools

Microsoft Word

Microsoft Excel

SharePoint

Job description

Lumen Bioscience is seeking a dedicated Quality Assurance (QA) Associate I to help maintain our quality management system in a cGXP regulated environment. You will support on-the-floor QA for manufacturing, review batch records, and assist with investigations and audits to ensure regulatory compliance.

The role emphasizes documentation integrity, data accuracy, and collaboration with QA leadership to uphold high quality standards in biotech operations.