Lumen Bioscience · 3 weeks ago
QC Specialist, Microbiology
Seattle, WA
Full-time
Onsite
Entry Level
$85K/yr - $95K/yr
2+ years expLumen Bioscience is a biotechnology company focused on advancing global health solutions. They are seeking a QC Specialist, Microbiology to establish and perform microbiological quality control testing in a GMP environment, ensuring compliance and supporting product release. The role involves executing microbiological assays, maintaining a compliant lab, and collaborating with cross-functional teams.
BiopharmaBiotechnologyLife Science
Responsibilities
Perform routine microbiological assays, including bioburden testing, microbial limits per USP, and environmental monitoring
Conduct adventitious agent screening or support external testing as needed
Prepare media, reagents, and microbiological cultures following SOPs and GMP requirements
Document results accurately in compliance with Good Documentation Practices (GDP)
Interpret results, identify trends, and escalate out-of-specification (OOS), out-of-trend (OOT), or atypical findings
Author and revise SOPs, test methods, and other controlled documents
Support qualification, calibration, and maintenance of microbiology laboratory equipment
Participate in method qualification/validation and QC readiness for GMP manufacturing
Assist with deviation investigations, CAPAs, and change controls as needed
Ensure work is performed in compliance with cGMP, GLP, and company quality policies
Perform routine environmental monitoring
Trend EM data and support investigation of excursions
Coordinate sample submission to external contract testing labs when required
Work closely with Process Development, Manufacturing, Quality Assurance, and external partners to support lot release and overall program timelines
Provide microbiology subject matter insights to support risk assessments, contamination control strategy, and process improvements
Qualification
Required
Demonstrated ability to coordinate and support multiple projects concurrently
Exceptional organizational skills with a keen eye for detail and accuracy
Strong written and verbal communication abilities to facilitate effective collaboration
Proactive and self-motivated approach to work, demonstrating initiative and problem-solving skills
Ability to work well under pressure and meet tight deadlines
Collaborative mindset with a focus on teamwork and building positive relationships
Proficient in Microsoft Office Suite, project management software (e.g., Smartsheets) and reference software (e.g., Zotero)
Ability to adapt quickly to changing priorities and requirements
Strong ethics and integrity, ensuring compliance with regulatory guidelines and company policies
Ability to sit for extended periods of time (2 or more hours)
Preferred
Bachelor's degree in a relevant scientific or healthcare discipline is preferred
2+ years of experience in a project coordination or administrative support role, preferably in the biopharmaceutical or clinical research industry
Benefits
Stock bonus
Health, Dental, and Vision premiums fully covered by Lumen
401k match up to 4%
Industry-leading PTO policy, paid refresh days, and paid year-end holiday office closure
Monthly wellness program to support your health and well-being
Free onsite parking or public transportation subsidies
Comprehensive parental leave policies
Life insurance, short & long-term disability, and access to employee assistance programs
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