Quality Control - Chemist II
Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: January 11, 2021
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Job Description:
Overview Summary: The Quality Control Chemist II, 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 release and stability testing using the
established analytical methods.External US Essential Functions:*
Perform QC analytical testing for GMP release and stability testing
as needed.* pH Conductivity & qPCR required* HPLC, Agarose Gel
Electrophoresis, UPLC, CE, IEF and/or UV/Vis Spectrometry
preferred* Osmolality testing* SDS Page & Western Blot* Executes
technical transfer, qualification and validation protocols as
needed.* Writes and revises Standard Operating Procedures (SOPs)
and other Good Manufacturing Practices (GMP) documentation as
appropriate.* Develop and support a system for managing test
samples, reagents and reference standards.* Reports excursion/out
of specifications results to the QC Departmental
Supervisor/Manager.* Provides OOS investigational support as
needed.* Ensure lab is maintained (organized, clean, properly
supplied).* Perform other duties as assigned.Required Skills &
Abilities:* Ability to analyze raw data, assess assay and system
suitability criteria. * Perform as a SME in the designated methods
transferred into FDBT.* 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. * AND 2
years of 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.
Keywords: FDBT - FUJIFILM Diosynth, College Station , Quality Control - Chemist II, Other , College Station, Texas
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