Quality Control Cell Biology Analyst III
Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: May 9, 2022
Overview Summary The Quality Control Cell Biology III 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.
External US Essential Functions:
- 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
- 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
- Perform other duties as assigned. -Required Skills & Abilities:
- Proficient in ELISA based methods, cell based assays and
qualification of critical reagents methodologies.
- Ability to analyze raw data, assess assay and system
- Strong critical thinking, time management and organizational
skills. Demonstrate the ability to multitask and consistently meet
- Ability to follow safety procedures outlined in the Chemical
- 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. -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
- 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. -Minimum Qualifications:
- Master's degree in science related field with two (2) years of
- Bachelor's degree in science related field with four (4) years
of experience; OR
- Associate's degree in science related field with six (6) years
- At least 2 years' industry experience in a GMP / GxP or a
comparable federally regulated environment.Preferred
- Degree in Biology.
- Familiar with monoclonal antibody testing methodology. -
- Experience in assay troubleshooting and problem solving.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. -Familiar
with GMP documentation and Quality Systems.
Keywords: FDBT - FUJIFILM Diosynth, College Station , Quality Control Cell Biology Analyst III, Professions , College Station, Texas
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