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 controlled environments.
- Ability to regularly lift up to 20 lbs and periodically lift up to 50 lbs.
Additional Skills & Qualifications
- Quality Control experience in an FDA-regulated industry supporting cGMP manufacturing areas.
- Previous experience working in a cleanroom environment, including aseptic gowning and behavior.
- Previous experience working in a cGMP cell and gene therapy manufacturing and/or testing facility.
- Experience working with a Laboratory Information Management System (LIMS).
- Experience with organism qualification, media qualification, and high-throughput environmental monitoring workflows.
- Exposure to or interest in release testing and analytical QC platforms.
- Interest in or exposure to Quality Assurance and broader Quality functions, with a willingness to learn and expand responsibilities.
- Demonstrated growth mindset, with the drive to learn new techniques, platforms, and systems in a fast-paced environment.
- Strong communication skills, with the ability to collaborate across teams and clearly document and hand off work.
- Proactive, thoughtful approach to planning and executing work so that it is predictable and easily transferred to others.
- Passion for groundbreaking science and technology, particularly in cell and gene therapy and immunotherapy.
- Commitment to a mission-driven environment focused on improving outcomes for patients and their families.
Job Type & Location
This is a Contract position based out of Louisville, CO.
Pay and Benefits
The pay range for this position is $34.16 - $42.20/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Louisville,CO.
Application Deadline
This position is anticipated to close on Aug 10, 2026.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.
Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.