QC Analyst - Microbiology at Neurona Therapeutics

South San Francisco, California, United States -

Full Time

Start Date

Immediate

Expiry Date

07 Jul, 26

Salary

0.0

Posted On

08 Apr, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Microbiology, Environmental monitoring, Cleanroom operations, Aseptic technique, cGMP, GxP, Data integrity, LIMS, ELN, Gram staining, Sterility testing, Endotoxin testing, Quality control, Root cause analysis, Documentation, Calibration

Industry

Biotechnology Research

Description

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. ```

Responsibilities

The QC Analyst will perform environmental monitoring and routine testing of raw materials and final drug products within a GMP manufacturing environment. They will also support batch release activities, maintain data integrity, and participate in investigations and technical documentation updates.