QC Analyst III, Microbiology

Location: College Station
Posted on: June 23, 2025

Job Description:

The work we do at FUJIFILM Diosynth Biotechnologies Texas has never been more important—and we are looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions. If you’re ready to help transform the future of medicine, join FUJIFILM Diosynth Biotechnologies. We offer a flexible work environment and we’re proud to cultivate a culture that will fuel your passion, energy, and drive—what we call Genki. Our state-of-the-art biomanufacturing facility is located in in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it’s a dynamic location that blends convenience with innovation. Essential Functions: • Responsible for QC microbiological aspects of cGMP compliance and testing. • Perform microbiological verifications as needed for finished product and in process controls and buffers. • Qualification of microbiological media, diluents, and organisms. • Qualification of APS media and inspection for turbidity • Biological Indicator Testing and qualification activities • Material Bioburden Testing and Bioburden Suitability • Bacterial Endotoxin Testing and Inhibition/Enhancement Testing for Product Samples and Buffers • Bacterial Identifications using the Biology and Fungal Identifications by the Macroscopic Identification method. • Sub-Visible particulate Testing by USP , and , Method 1 and Method 2 • Participate in the investigation and review of alert and action limit investigations as needed and implements corrective action as appropriate. • Participate in the investigation of microbiological data deviations and PRs. • Develop and/or contribute toward creating and revising microbiological Standard Operating Procedures (SOPs) and other current Good Manufacturing Practices (cGMP) documentation. • Review of EM and product release data. • Ensure lab is maintained (organized, clean, properly supplied) • Perform other duties as assigned. Required Skills & Abilities: • Sound aseptic technique and understanding of industry best practices, techniques, equipment, and materials. • Ability to analyze raw data, assess assay and system suitability criteria. • Ability to follow safety procedures outlined in the Chemical Hygiene Plan. • Utilize SDS sheets to properly assess chemical hazards, spill response procedures, and PPE requirements if indicated. • Good attention to detail and ability to utilize problem solving/trouble shooting skills. • Good computer skills. • Work under minimal supervision. • Demonstrated written and oral communication skills. • Demonstrated leadership skills. • Strong organization and analytical skills. Minimum Qualifications: • Bachelor’s degree preferably in Biochemistry, Chemistry, Biology, or related field with two (2) years of relevant GMP experience; OR • Associate of Science preferably in Biochemistry, Chemistry, Biology, or related field with three (3) years of relevant experience; OR • High School Diploma or GED with four (4) years of relevant experience; • AND at least one (1) year of previous GMP experience. Working Conditions & Physical Requirements: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to: • Experience prolonged standing, some bending, stooping, and stretching. • Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required. • Ability to sit for long periods to work on a computer. • Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials. • Ability to lift/pull/push 50 lbs on occasion and 15 lbs regularly. • Ability to wear personal protective equipment including safety glasses, lab coat, and gloves. • Attendance is mandatory.

Keywords: , Missouri City , QC Analyst III, Microbiology, Science, Research & Development , College Station, Texas