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Quality Control Microbiology Specialist
Houston, TX, US
Scientific
Bachelors Degree
Full Time, Temporary
Experienced (Non-Manager)
On-site
Biotechnology/Pharmaceuticals
First Shift (Day)
Houston, TX, US
Experienced (Non-Manager)
Full Time, Temporary
Biotechnology/Pharmaceuticals
On-site
Scientific
Bachelors Degree
First Shift (Day)
Job details
Quality Control Microbiology Specialist
Kelly science & Clinical is seeking a Quality Control Microbiology Specialist to join our client’s QC team.
As the QC Microbiology Specialist you will play a leading role in microbiological testing, environmental monitoring, and data analysis within a cGMP production environment. This individual will oversee QC Microbiology activities, ensure compliance with regulatory standards, and contribute to process improvements and method validations.
Key Responsibilities
• Perform and evaluate microbiological testing and environmental monitoring activities.
• Oversee daily operations within the microbiology laboratory.
• Manage media and microbe qualification testing in support of EM and/or bioburden/sterility testing.
• Draft and review SOPs, protocols, reports, environmental monitoring excursions, OOS investigations, and other GMP documentation.
• Develop study designs and conduct data/statistical analysis; present findings in written and oral formats.
• Review microbiology data for accuracy and GMP compliance, and identify trends or anomalies.
• Collaborate cross-functionally with Manufacturing, Quality Assurance, and Procurement teams.
• Troubleshoot microbiological assays and contribute to CAPA investigations as needed.
• Ensure adherence to FDA, EMA, USP, EP, and ICH guidelines for biologics and cleanroom operations.
Required Qualifications
• B.S., M.S., or Ph.D. in Microbiology, Biology, or a related field.
o B.S./M.S. with 2–4+ years, or Ph.D. with relevant experience in microbiology in a cGMP environment.
• In-depth knowledge of ISO standards for GMP cleanrooms and compendial methods (USP, EP).
• Hands-on experience with:
o Environmental monitoring (air, surface, personnel).
o Bioburden, sterility, mycoplasma, and endotoxin testing.
o Microbial culturing and identification using stains, PCR, and other methods.
• Strong data management and documentation skills.
• Familiarity with deviation investigations, CAPA, and root cause analysis.
• Ability to work independently and collaboratively in a fast-paced, multidisciplinary environment.
• Willingness to work flexible hours, including weekends and holidays when needed.
• Must be able to gown for aseptic work in controlled cleanroom environments.
Preferred Skills
• Experience with media fill validation, microbial trending, and risk assessment.
• Strong technical writing and communication skills.
• Detail-oriented with a proactive approach to continuous improvement.
• Knowledge of cGDP, cGLP, and quality system regulations.
Working Conditions
• On-site role requiring full aseptic gowning for cleanroom entry.
• Occasional weekend and holiday work may be required based on operational needs.
This is a 3-month temp position with the possibility of extension. The work schedule is Monday-Friday, 8am-5pm with occasional weekend and holiday work. If you meet the above qualifications, please submit your resume for immediate consideration. #P1
9843928
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Why Kelly® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.About Kelly
Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.