What are the responsibilities and job description for the QC Analyst - Microbiology position at Neurona Therapeutics?
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
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.
- 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.
- 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.
Salary : $80,000 - $90,000