QC Specialist, Microbiology

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.

Skills and Attributes:

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

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).