Quality Control - Microbiology Analyst III
Company: FUJIFILM Holdings America Corporation
Location: College Station
Posted on: September 14, 2023
Job Description:
Quality Control - Microbiology Analyst III
Job Locations
US-TX-College Station
Requisition ID
2023-24762
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. Summary:
The Microbiologist III will be responsible for the QC
microbiological aspects of cGMP compliance and testing at the
FUJIFILM Diosynth Biotechnologies Texas (FDBT) Quality Control
Laboratory.
External US
Essential Functions:
Responsible for QC microbiological
aspects of cGMP compliance and testing.Perform microbiological
verifications as needed for finished product and in process
controls and buffers.Qualification of microbiological media,
diluents, and organisms.Qualification of APS media and inspection
for turbidityBiological Indicator Testing and qualification
activitiesMaterial Bioburden Testing and Bioburden
SuitabilityBacterial Endotoxin Testing and Inhibition/Enhancement
Testing for Product Samples and BuffersBacterial Identifications
using the Biology and Fungal Identifications by the Macroscopic
Identification method.Sub-Visible particulate Testing by USP , and
, Method 1 and Method 2Participate in the investigation and review
of alert and action limit investigations as needed and implements
corrective action as appropriate.Participate in the investigation
of microbiological data deviations and PRs. Develop and/or
contribute toward creating and revising microbiological Standard
Operating Procedures (SOPs) and other current Good Manufacturing
Practices (cGMP) documentation.Review of EM and product release
data.Ensure lab is maintained (organized, clean, properly
supplied)Perform other duties as assigned.
Required Skills & Abilities:
Sound aseptic technique and
understanding of industry best practices, techniques, equipment,
and materials. Ability to analyze raw data, assess assay and system
suitability criteria. 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.Good attention to detail and ability to utilize
problem solving/trouble shooting skills.Good computer skills.Work
under minimal supervision.Demonstrated written and oral
communication skills.Demonstrated leadership skills.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:
Bachelor's degree preferably in
Biochemistry, Chemistry, Biology, or related field with two (2)
years of relevant GMP experience; ORAssociate of Science preferably
in Biochemistry, Chemistry, Biology, or related field with three
(3) years of relevant experience; ORHigh School Diploma or GED with
four (4) years of relevant experience;AND at least one (1) year of
previous GMP experience. 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 , Quality Control - Microbiology Analyst III, Professions , College Station, Texas
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