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.

Duties & Responsibilities:

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.

Qualifications & Requirements:

• Education and Experience:
  • 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
• Skills and Attributes:
  • 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

Physical Requirements:

• Ability to sit for extended periods of time (2 or more hours)

Benefits at Lumen Bioscience:

• 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

At Lumen Bioscience, we foster a workplace built on collaboration, innovation, and professional growth. This role offers a significant opportunity to contribute directly to cutting-edge biotechnology and the advancement of global health solutions.

Join us to shape innovative solutions and drive operational excellence.