Microbiology QC Associate I: Cleanroom Testing & Data

Tanvex BioPharma Inc.; San Diego, Northern (CA, KY); Hybrid; USD 60,000 - 75,000; Full time

Job summary

Tanvex BioPharma Inc. in San Diego, CA is seeking a Quality Control Associate I, Microbiology to perform routine environmental and utilities monitoring of cGMP manufacturing facilities.

The role conducts microbiological and chemical testing including endotoxin, bioburden, TOC, and conductivity to support product release and facility compliance. You will assist with data trending, support method validation activities, and contribute to drafting protocols, reports, and SOPs related to

Qualifications

• BS or advanced degree in a related scientific discipline, or equivalent combination of education and experience.
• 0–2 years of progressively responsible experience in pharmaceutical or biologics production environments.

Responsibilities

• Conduct Bioburden and endotoxin testing of in-process and product samples.
• Perform environmental monitoring (EM) of classified cleanrooms and controlled areas.
• Collect and test water samples from purified water and WFI systems.
• Maintain accurate and compliant documentation per cGMP, GDP, and SOPs.
• Assist investigations of microbiological deviations and support CAPA implementation.
• Collaborate with Manufacturing, QA, and Validation teams.
• Manage sample handling, logging, storage, and disposal per SOPs and regulatory requirements.

Skills

GLP & cGMP knowledge

Microbiology techniques

Documentation practices

Microsoft Office

Analytical thinking

Education

BS or higher in a related science field

Tools

Analytical instruments

Job description

Tanvex BioPharma Inc. in San Diego, CA is seeking a Quality Control Associate I, Microbiology to perform routine environmental and utilities monitoring of cGMP manufacturing facilities.

The role conducts microbiological and chemical testing including endotoxin, bioburden, TOC, and conductivity to support product release and facility compliance. You will assist with data trending, support method validation activities, and contribute to drafting protocols, reports, and SOPs related to