The Microbiology Analyst II will be responsible for the QC microbiological aspects of cGMP compliance and testing at the FujiFilm Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory.
- Performs QC microbiological aspects of cGMP compliance and testing.
- Collect environmental monitoring (Total Air, Viable Air and Viable Surface) in a cleanroom/controlled environment
- Collect Utility Monitoring Samples (RODI/WFI) routinely and for qualification of systems.
- Perform incubation/enumeration of environmental samples
- Gram stain/Characterization of environmental isolates
- Performs testing for water samples (pH/Conductivity, TOC, Water Bioburden, Endotoxin)
- 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.
- Demonstrated written and oral communication skills.
- Demonstrated leadership skills.
- Strong organization and analytical skills.
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.
- Master's degree preferably in Biochemistry, Chemistry, Biology or related field, or
- Bachelor's degree preferably in Biochemistry, Chemistry, Biology or related field with one (1) year of relevant GMP experience
- Associate of Science degree with one (2) year of relevant GMP experience
- High School Diploma or GED with two (3) years of relevant GMP experience.
We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state, or local law.
If an accommodation to the application process is needed, please email FDBTHR@fujifilm.com or call 979-431-3528.