Lumen Bioscience · 5 hours ago
QA Associate, OTF Support (temporary)
Seattle, WA
Full-time
Onsite
Entry Level
$27/hr - $30/hr
1+ years expLumen Bioscience is seeking a QA Associate for OTF Support in a temporary position. In this role, you will help maintain the quality management system by supporting cGLP/cGMP/cGCP activities and ensuring compliance with regulatory standards.
BiopharmaBiotechnologyLife Science
Responsibilities
Perform document scanning and archival of controlled records
Maintain accurate records of activities
Perform on-the-floor support for manufacturing operations
Perform issuance of process documentation for scheduled manufacturing operations
Perform review of Batch records and related process documentation
Conduct facility and operations walkthroughs to ensure compliance with the Company’s 21 CFR part 210 /211 standard pharmaceutical cGxP quality processes
Support the QA Manager and QA Specialist in all QA related tasks
May assist in the preparation of metrics reports
May assist with the investigation and triage of deviations, CAPAs, or other quality events
Qualification
Required
Minimum 1 year of work experience in a regulated (cGXP) organization or a minimum of an associate's degree in a relevant scientific field
Knowledge of relevant cGMP, ISO 9001, and ICH requirements for document control and quality records
High level of proficiency in Microsoft Word, Excel, and SharePoint
Well-organized and detail-oriented with strong technical skills, excellent written and verbal communication skills, and proven ability to multitask
Strong interpersonal skills and the ability to effectively collaborate with others in a dynamic team environment
Capable of supporting multiple projects simultaneously in a deadline-driven environment
Adaptability, flexibility, independence, and resourcefulness to thrive in a fast-paced, small-company environment
High integrity and ethics
Commitment to quality and timely delivery of results
Benefits
Free onsite parking
Company
Lumen Bioscience
Lumen Bio discovers, develops, and manufactures biologic drugs and vaccine candidates for various diseases.
51-200 employees
H1B Sponsorship
Lumen Bioscience has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (2)
Funding
Current Stage
Growth StageTotal Funding
$96.95MKey Investors
WestRiver GroupU.S. Department of DefenseMedical Technology Enterprise Consortium
2025-10-08Series C· $30M
2023-10-17Grant· $16.2M
2023-05-11Grant· $8.8M
Leadership Team
Brian Finrow
CEO & Founder
Craig Behnke
Executive Vice President, Production and Development
Recent News
2025-10-17
Company data provided by crunchbase