QA Associate I – cGXP Compliance & Documentation

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

Benefits offered by this job

Health benefits

401k match

Stock bonuses

Paid time off

Wellness programs

Job summary

Lumen Bioscience is seeking a dedicated Quality Assurance (QA) Associate I to support the company’s quality management system and regulatory compliance across cGXP standards. The role emphasizes on-the-floor QA, document control, and thorough record reviews to ensure manufacturing operations align with 21 CFR parts 210/211.

Ideal candidates have an Associate's degree or 1 year in a regulated environment, strong MS Word/Excel/SharePoint skills, and a keen eye for detail.

Qualifications

• Educational Background: Associate's degree in a relevant scientific field, or at least 1 year of work experience in a regulated cGXP environment.
• Technical Knowledge: Familiarity with cGMP, ISO 9001, and ICH requirements related to document control and quality records.
• Technical Skills: High proficiency in Microsoft Word, Excel, and SharePoint.
• Personal Attributes: Strong organizational skills, detail-oriented, ability to multitask, excellent communication skills, adaptability, and commitment to quality and ethical standards.

Responsibilities

• Maintain organized documentation through scanning, archiving, and record-keeping.
• Issue and review process documentation associated with manufacturing schedules.
• Support on-the-floor quality assurance for manufacturing compliance.
• Perform facility walkthroughs to ensure adherence to pharmaceutical regulatory requirements.
• Assist with investigations and management of deviations, CAPAs, and other quality-related events.
• Support internal and external audits, validation, qualification, and verification activities as needed.

Skills

Attention to detail

Organizational skills

Strong communication

Multitasking

Education

Associate's degree in a relevant scientific field

Tools

Microsoft Word

Excel

SharePoint

Job description

Lumen Bioscience is seeking a dedicated Quality Assurance (QA) Associate I to support the company’s quality management system and regulatory compliance across cGXP standards. The role emphasizes on-the-floor QA, document control, and thorough record reviews to ensure manufacturing operations align with 21 CFR parts 210/211.

Ideal candidates have an Associate's degree or 1 year in a regulated environment, strong MS Word/Excel/SharePoint skills, and a keen eye for detail.