Quality Assurance Associate I

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

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.
• QA Team Support: Assist the QA Manager and QA Specialist in various quality assurance tasks, including metric report preparation and quality event investigations.

Essential Duties and 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.

Qualifications & Requirements:

• 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.

Physical Requirements:

• Ability to sit and stand for extended periods (2+ hours each).
• Occasionally lift or carry items up to 20 kg.

Salary & Benefits at Lumen Bioscience:

• $65,000 - $70,000 annually
• Health, Dental, and Vision premiums fully covered by Lumen.
• 401k match up to 4%, in addition to annual stock bonuses for all employees.
• Industry-leading PTO policy, paid refresh days, and year-end holiday office closure.
• Monthly wellness programs to support employee health.
• Free onsite parking or public transportation subsidies.
• Life insurance, short & long-term disability, and employee assistance programs.

At Lumen Bioscience, we foster a collaborative and innovative work environment where your contributions directly impact biotechnology and global health solutions.

Join us and play a vital role in maintaining exceptional quality standards and regulatory compliance.

Compensation Range

$65,000 - $70,000 USD

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Lumen Bioscience’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.