QC Analyst - Microbiology

Location: South San Francisco, CA, 94080
About Neurona Therapeutics

Neurona Therapeutics is a clinical-stage biotechnology company based in South San Francisco focused on developing neuronal cell-based therapies for intractable neurological diseases. We are seeking a highly motivated and detail-oriented candidate to join our Quality Control team. Our ideal candidate is organized, has strong hands-on laboratory experience, and can thrive in a fast-paced, dynamic, and collaborative environment.
Role Overview

The QC Analyst will report directly to the Associate Manager, Quality Control, and support day-to-day Quality Control laboratory operations for Neurona's cell therapy programs. A primary focus of this role will be environmental monitoring within a GMP manufacturing environment, with opportunities to be cross-trained on additional QC assays. The QC Analyst will play a critical role in supporting batch release, maintaining data integrity, and partnering cross-functionally with Manufacturing, Quality Assurance, and Process Sciences to ensure high-quality and compliant operations.
Responsibilities

• Perform environmental monitoring (EM) activities including viable and non-viable air sampling, surface monitoring, and personnel monitoring in classified cleanroom environments.
• Perform routine and non-routine QC testing of raw materials, in-process samples, and final drug product (e.g., Gram staining, sterility and endotoxin testing).
• Execute testing in compliance with cGMP, SOPs, and regulatory requirements.
• Maintain accurate, complete, and well-organized documentation in laboratory systems (e.g., LIMS, ELN) to ensure data integrity.
• Support batch release activities through timely and reliable test execution.
• Participate in investigations (e.g., deviations, OOS/OOT results) and support root cause analysis.
• Assist in authoring and revising SOPs, test methods, and technical documents.
• Maintain a clean, organized, and inspection-ready laboratory environment.
• Support method qualification, transfer, and validation activities as needed.
• Collaborate cross-functionally with Manufacturing, Quality Assurance, and Process Sciences.
• Assist with equipment maintenance, calibration, and troubleshooting.
• Follow all safety and biosafety procedures when handling biological materials.
• Promote adherence to GMP, GxP, and Data Integrity best practices within the QC laboratory.
• Cross-train and support additional QC assays and testing as needed.

Required Qualifications

• 2-3 years of hands-on experience in microbiology within a QC or GMP-regulated laboratory environment; cell therapy experience strongly preferred.
• Direct experience performing environmental monitoring (EM) in cleanroom/GMP environments strongly preferred.
• Hands-on experience with air and surface sampling, colony counting and aseptic technique.
• Working knowledge of cGMP/GxP regulations and documentation practices.
• Strong attention to detail with a high level of organization and data integrity focus.
• Ability to follow structured procedures with precision.
• Strong communication and collaboration skills in a cross-functional environment.
• Ability to manage multiple priorities in a fast-paced, clinical-stage environment.

Education Requirements

• Bachelor of Science in Biology, Chemistry, Biochemistry, or related scientific discipline.
• 2-3 years of relevant industry experience with a strong emphasis in microbiology and environmental monitoring.

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