QC Analyst II/III, Cell Biology

Overview

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.

External US

The Quality Control Analyst II/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. The Quality Control Analyst II/III, Cell Biology will be responsible for participating in the Technology Transfer of established methods into the Fujifilm Diosynth Biotechnologies Texas (FDBT) Quality Control Laboratory.

Reports to                QC Manager, Cell Biology

Work Location         College Station, TX 

Primary Responsibilities:

Quality Control Analyst II:

• 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.
• Perform ELISA based methods, cell based assays and qualification of critical reagents methodologies.
• Execute tech transfer, qualification, and validation protocols as needed.
• Contribute to writing and revising Standard Operating Procedures (SOPs) and other Good Manufacturing Practices (GMP) documentation as appropriate.
• Support the establishment of a system for managing test samples, reagents and reference standards.
• Report excursion/out-of-specification results to QC Departmental management.
• Assist in the preparation of technical proposals, amendments, reports and memoranda.
• Provides OOS investigational support as needed.

Quality Control Analyst III:

• 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.

Qualifications:

Quality Control Analyst II:

• Bachelor’s degree preferably in Biology or Biochemistry with two (2) years’ of relevant laboratory experience; OR
• Associates degree preferably in Biology or Biochemistry with three (3) years’ of relevant laboratory experience.
• AND one (1) year of experience in a GLP/GxP or a comparable federally regulated environment.

Quality Control Analyst III:

• Master’s degree in science related field with 2 years of experience; OR
• Bachelor’s degree in science related field with 4 years of experience; OR
• Associate’s degree in science related field with 6 years of experience.
• 2 years’ industry experience in a GMP/GxP or a comparable federally regulated environment.

Quality Control Analyst II & III:

• Familiar with monoclonal antibody testing methodology preferred.
• Experience in assay troubleshooting and problem solving preferred.
• 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.

Join us!  FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential.  We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community and the world at large.

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 979-431-3500.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.