QC Specialist, Microbiology

Join Lumen Bioscience as a QC Specialist, Microbiology to help establish and perform microbiological quality control testing that supports process development, manufacturing, and product release in an early-stage GMP environment. In this role, you will execute routine and non-routine microbiological assays, including bioburden testing, microbial limits per USP, and environmental monitoring, while helping maintain a compliant QC microbiology lab.

This position is a strong fit for someone who enjoys hands-on lab work and brings solid quality and compliance fundamentals. You will prepare media, reagents, and cultures, document results accurately using Good Documentation Practices, interpret results and trends, and escalate OOS, OOT, or atypical findings. You will also support method qualification and validation, equipment qualification, calibration, and maintenance, and contribute to quality systems by authoring and revising SOPs, test methods, and controlled documents. You will assist with deviation investigations, CAPAs, and change controls as needed, and partner closely with Process Development, Manufacturing, Quality Assurance, and external partners to support lot release and program timelines. If you are detail-oriented, organized, proactive, and comfortable building structure in an evolving environment, with a strong commitment to quality and compliance, we encourage you to apply.

This position requires working under the 21 CFR part 210/211 standard pharmaceutical cGXP quality system processes.

• →Microbiology Testing & Analysis
  • →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.
• →Quality Systems & Compliance
  • →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.
• →Environmental Monitoring & Facility Support
  • →Perform routine environmental monitoring.
  • →Trend EM data and support investigation of excursions.
  • →Coordinate sample submission to external contract testing labs when required.
• →Cross-Functional Collaboration
  • →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.

• Education and Experience:
  • Minimum 6 years of work experience in Quality Control in a regulated (cGXP) organization.
  • -OR- a PhD in biochemistry, microbiology, or related scientific field plus 2 years of hands-on microbiology experience in a pharmaceutical, biotech, or regulated laboratory environment.
  • -OR- a bachelor’s or master’s degree in biochemistry, microbiology or related scientific field plus 5 years of hands-on microbiology experience in a pharmaceutical, biotech, or regulated laboratory environment.
  • Knowledge of relevant cGxP, ISO 9001, and ICH requirements for document control and quality records.
  • Operational experience with PCR-based methods (dPCR preferred; qPCR and RT-PCR helpful).
  • Operational experience with direct ELISA-based methods.
  • Strong leadership and mentoring experience.
• Skills and Attributes:
  • Hands-on, detail-oriented, and organized.
  • Strong communication skills across technical and non-technical teams.
  • Comfortable building structure in ambiguous or evolving environments.
  • Proactive problem-solver who enjoys continuous improvement.
  • High level of integrity and commitment to quality.
  • Experience supporting clinical-stage or commercial GMP operations.
  • Familiarity with method validation, equipment qualification, and QC lab setup.
  • Familiarity with the MSD platform.
  • Experience with regulatory inspections or QA/QC audits.
  • Ability to support weekend or off shift testing as needed in a startup environment.

• Ability to work on-site in Seattle, WA
• Ability to sit/stand for extended periods of time (2 or more hours)
• Occasionally lift or carry up to 23 kg