QC Analyst II, Microbiology

at  Fujifilm

THE WORK WE DO AT FDB HAS NEVER BEEN MORE IMPORTANT—AND WE ARE LOOKING FOR TALENTED CANDIDATES TO JOIN US. WE ARE GROWING OUR LOCATIONS, OUR CAPABILITIES, AND OUR TEAMS, AND LOOKING FOR PASSIONATE, MISSION-DRIVEN PEOPLE LIKE YOU WHO WANT TO MAKE A REAL DIFFERENCE IN PEOPLE’S LIVES. JOIN FDB AND HELP CREATE THE NEXT VACCINE, CURE, OR GENE THERAPY IN PARTNERSHIP WITH SOME OF THE MOST INNOVATIVE BIOPHARMA COMPANIES ACROSS THE GLOBE. WE ARE PROUD TO CULTIVATE A CULTURE THAT WILL FUEL YOUR PASSION, ENERGY AND DRIVE - WHAT FDB CALL GENKI.

External US:
The Microbiologist II will be responsible for the QC microbiological aspects of cGMP compliance and testing at the FUJIFILM Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory.
Reports to Supervisor, Microbiology
Work Location College Station, TX

QUALIFICATIONS:

• Bachelor’s degree preferably in Biochemistry, Chemistry, Biology, or related field with 1+ year of relevant GMP experience; OR
• Associates degree preferably in Biochemistry, Chemistry, Biology, or related field with 2+ years of relevant GMP experience; OR
• High School Diploma or GED with 3+ years of relevant GMP experience.
• 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.
• Role model for company core values of trust, delighting our customers, Gemba, and Genki.

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.

PRIMARY RESPONSIBILITIES:

• 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.

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