QC Analyst III, Cell Biology - Second Shift

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:
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.
The Quality Control Analyst III, Cell Biology will be responsible for assisting in the qualification of test methods for in-process and final products. Be able to work under minimal supervision. Perform advanced assays requiring precise analytical skills and understanding of cell biology and immunology principles.
Reports to QC Supervisor/Manager, Cell Biology
Work Location College Station, TX

QUALIFICATIONS:

• Bachelor’s degree in science related field with 3+ years of experience; OR
• Associate’s degree in science related field with 5+ years of experience.
• 2+ years’ industry experience in a GMP/GxP or a comparable federally regulated environment.
• Degree in Biology preferred.
• Familiar with monoclonal antibody testing methodology preferred.
• Experience in assay troubleshooting and problem solving preferred.
• Familiar with GMP documentation and Quality Systems.
• Proficient in ELISA based methods, cell-based assays and qualification of critical reagents methodologies.
• Ability to analyze raw data, assess assay and system suitability criteria.
• Strong critical thinking, time management and organizational skills. Demonstrate the ability to multitask and consistently meet deadlines.
• 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.
• Excellent attention to detail.
• Computer proficiency required.
• Excellent written and oral communication skills.
• Excellent 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 wear personal protective equipment including safety glasses, lab coat, and gloves.
• Attendance is mandatory.

PRIMARY RESPONSIBILITIES:

• Participate in training the QC Bioassay Staff at FDBT in the established release methods.
• Perform QC analytical testing for GMP release and stability testing as needed.
• Executes tech transfer, qualification and validation protocols as needed.
• Contributes to writing and revising Standard Operating Procedures (SOPs), Technical Reports, and other Good Manufacturing Practices (GMP) documentation as appropriate.
• Maintain data integrity and compliance with company SOPs and specifications, FDA, and cGMP regulations.
• Participate in functions involving teams which impact timelines, improve quality and increase efficiency.
• Complete all testing, including special project/protocol testing in a timely and appropriate manner.
• Must communicate effectively (verbal and written) with supervisors and peers and be able to work cross-functionally with other groups.
• 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 wear personal protective equipment including safety glasses, lab coat, and gloves.
• Attendance is mandatory