QC Analyst II/III, Cell Biology
Company: FUJIFILM Holdings America Corporation
Location: College Station
Posted on: September 14, 2023
Job Description:
QC Analyst II/III, Cell Biology
Job Locations
US-TX-College Station
Requisition ID
2023-24624
Category
Quality Control
Company (Portal Searching)
FUJIFILM Diosynth Biotechnologies
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 BiologyWork 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; ORAssociates 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; ORBachelor's degree in science related field with 4+
years of experience; ORAssociate'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.
Keywords: FUJIFILM Holdings America Corporation, College Station , QC Analyst II/III, Cell Biology, Professions , College Station, Texas
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