Quality Control - Chemist III
Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: January 12, 2021
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Job Description:
Overview Summary: The Quality Control Chemist III, with limited
supervision, will be responsible for participating in the
Technology Transfer of established methods into the FUJIFILM
Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory.
Following Tech-Transfer Activities, the candidate will be
responsible for performing in-process, release and stability
testing using the established analytical methods.External US
Essential Functions:* Perform QC analytical testing for GMP
in-process, release and stability testing as needed:* PH
Conductivity & qPCR required* HPLC, RP-HPLC, SEC, Agarose Gel
Electrophoresis, UPLC, CE, IEF, Protein Purity Assay, Peptide
Mapping, DNA Sequencing and/or UV/Vis Spectrometry preferred*
Residual Analysis and/or Surfactant Analysis* Osmolality testing*
Executes technical transfer, qualification and validation protocols
as needed.* Technical Writing to include:* Writes and revises
Standard Operating Procedures (SOPs) and other Good Manufacturing
Practices (GMP) documentation as appropriate.* Qualification
protocols* Transfer Protocols* Creating manuals for
processes/activities* Sample plans (support & edit)* Assisting and
initiating closure of deviations, CAPAs and Change Controls*
Reviewing Methods for accuracy:* HPLC, Chromatography (Ion
Exchange, SEC, RP-HPLC, Residual Analytes)* Assist with technical
training of less experienced members of the team.* Facilitate the
maintenance and repair of equipment* Develop and support a system
for managing test samples, reagents and reference standards.*
Reviews data obtained for compliance to specifications and reports
excursion/out of specifications* Provides OOS investigational
support as needed.* Provides QC support for the sites Environmental
Monitoring program and raw material analysis.* Perform other duties
as assigned.Required Skills & Abilities:* Ability to analyze raw
data, assess assay and system suitability criteria, understand
process from beginning to end, and explain process. * Excellent
communication skills.* Ability to work independently or in a team.*
Perform as a SME in the designated methods transferred into FDBT.*
Previous pipetting experience. * Ability to follow safety
procedures outlined in the Chemical Hygiene Plan.* Utilize MSDS
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 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. * Ability
to lift up to 30 pounds on occasion.* Attendance is
mandatory.Minimum Qualifications:* Master's degree in Chemistry,
Biochemistry or related degree, with 1 year hands on laboratory
experience; OR* Bachelor's degree in Chemistry, Biochemistry or
related degree with 2 years hands on laboratory experience; OR*
Associates degree in Chemistry, Biochemistry or related degree with
4 years of hands on laboratory experience,* AND 2 years' industry
experience in a GMP / GxP or a comparable federally regulated
environment.Preferred Qualifications: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 e-mail FDBTHR@fujifilm.com or
call 979-431-3528.
Keywords: FDBT - FUJIFILM Diosynth, College Station , Quality Control - Chemist III, Other , College Station, Texas
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