Senior Analyst, Quality Control Microbiology

Senior Analyst, Quality Control Microbiology

Job Description

The Senior Analyst, Quality Control Microbiology plays a key role in ensuring the quality and safety of advanced cell and gene therapy products by performing and reviewing a wide range of microbiological quality control activities in a cGMP-regulated environment. This position supports environmental monitoring, clean utility testing, microbiological qualification, and method and equipment qualification while contributing to a culture of integrity, collaboration, and continuous improvement.

The role is ideal for a hands-on QC professional who thrives in a dynamic, mission-driven setting and is passionate about work that directly impacts patients' lives.

Responsibilities

+ Perform and review routine Quality Control microbiology laboratory activities, including environmental monitoring, clean utility sampling and testing, microbiological material qualification and maintenance, microbial identification, raw material sampling and inspection, bioburden testing, endotoxin testing, compendial testing, and container closure integrity testing.

+ Generate, revise, and maintain Quality Control documents in accordance with established document management processes, ensuring accuracy, compliance, and timely completion.

+ With management oversight, execute qualification and validation activities for QC laboratory equipment, instruments, systems, and methods to ensure they remain in a validated and compliant state.

+ Initiate and support microbial excursion investigations related to facility and personnel monitoring programs, including environmental monitoring, aseptic gowning, and utility monitoring, by collaborating closely with cross-functional partners such as Engineering, Manufacturing, and MSAT.

+ Apply and advance Operational Excellence and LEAN principles within the QC laboratories to drive continuous improvement across programs, processes, and systems.

+ Prepare, ship, and track samples to external testing laboratories, ensuring proper documentation, chain of custody, and timely delivery.

+ Support on-the-floor GMP activities by executing laboratory work in compliance with cGMP and GDP requirements, including proper documentation and adherence to standard operating procedures.

+ Perform organism qualification, media qualification, and high-throughput environmental monitoring work to support robust microbiological control programs.

+ Shepherd document changes through the document management system, including drafting, revising, and coordinating approvals for QC procedures and related documents.

+ Collaborate with team members and other departments to ensure work is executed predictably and can be effectively handed off, demonstrating proactive planning and clear communication.

+ Contribute to additional duties within the Quality organization as needed, including supporting release testing, analytical QC platforms, Quality Assurance, and broader Quality Control initiatives for candidates with a growth mindset.

+ Demonstrate and model core values by prioritizing doing the right thing over the easy thing, speaking up when issues arise, and maintaining high ethical and quality standards.

+ Participate in and support a culture that emphasizes integrity, teamwork, and thoughtful execution of work, always considering the impact on the next person and on patients.

Essential Skills

+ Bachelor's degree in Biochemistry, Molecular and Cellular Biology, Immunology, Biology, or another life science discipline.

+ 3-5 years of experience working in a cGMP-regulated Quality Control environment.

+ Demonstrated experience performing microbiology-focused QC activities such as environmental monitoring, clean utility sampling and testing, bioburden testing, endotoxin testing, compendial testing, and container closure integrity testing.

+ Strong understanding and practical application of cGMP and Good Documentation Practices (GDP) in a regulated laboratory setting.

+ Experience generating, reviewing, and managing QC documentation within a formal document management system.

+ Familiarity with Operational Excellence and Continuous Improvement philosophies, including LEAN concepts, with hands-on application in a regulated laboratory environment.

+ Ability to work effectively on the manufacturing floor and in QC laboratories while executing work under GMP conditions.

+ Ability to support and participate in microbial excursion investigations and environmental monitoring programs.

+ Strong teamwork orientation and a demonstrated commitment to shared goals, team success, and contributing to a positive workplace culture.

+ High level of integrity, with a willingness to raise concerns, ask questions, and prioritize quality and patient safety.

+ Ability to work on-site 5 days per week at the manufacturing facility.

+ Ability to work evenings and/or weekends as needed to support laboratory and manufacturing operations.

+ Ability to aseptically gown and work while standing for extended periods in manufacturing and…