Quality Control Visual Inspection Analyst II

at  Fujifilm

FOLLOW YOUR GENKI TO FUJIFILM DIOSYNTH BIOTECHNOLOGIES (FDB)

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.
College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas’ population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.

SUMMARY:

The Visual Inspection Analyst II will be responsible for assisting the drug product visual inspection program at FujiFilm Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory.
External US:

REQUIRED SKILLS & ABILITIES:

• Must be able to pass a visual acuity test, with corrective lenses if necessary.
• Ability to follow safety procedures outlined in the Chemical Hygiene Plan.
• Good attention to detail and ability to utilize problem solving/trouble shooting skills.
• Good computer skills.
• Demonstrated written and oral communication skills.
• Ability to multi-task and prioritize work assignments with little supervision.
• 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.

MINIMUM QUALIFICATIONS:

• Associate of Science or Bachelor’s degree preferably in Biochemistry, Chemistry, Biology or related field or
• High School Diploma or GED with one (1) years of relevant GMP experience.
• Role is contingent on passing a visual acuity test, with corrective lenses if necessary, prior to onboarding.

ESSENTIAL FUNCTIONS:

• Perform visual inspection for Final Product Fills and Aseptic Process Simulations (APS) for AQL level inspections
• Participate in threshold study (POD) executions and training exercises for visual inspection
• Participate in particulate identifications and investigations, as required.
• Investigate Action and Alert limit excursions and implement corrective and preventative actions, as needed.
• Identify and assist in deviations and report possible preventative and corrective actions.
• Sub-visible particulate testing (USP <787>, <788> (Method 1 and Method 2), <789>), as appropriate
• Participate in Container Closure Integrity Testing (CCIT) in-house and outsourcing, as required
• Draft and revise Standard operating procedures for the visual inspection program, as needed
• Secondary functions could include: environmental monitoring (Total Air, Viable Air and Viable Surface) in a cleanroom/controlled environment, plate count enumeration and characterization, routine QC laboratory cleaning, management of inventory items for the laboratory
• Ensure the 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