Hiring Quality Control Cell Biology Analyst II
Company: FUJIFILM Diosynth Biotechnologies
Location: College Station
Posted on: June 13, 2021
Overview Summary The Cell Biology Analyst II will be responsible
for participating in the Technology Transfer of established methods
into the FujiFilm Biotechnologies Diosynth Texas (FDBT) Quality
Control Laboratory. External US Essential Functions: 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. Perform other duties as assigned. Required
Skills & Abilities: 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. Perform as a SME in the designated methods transferred
into FDBT from FDBU. 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. 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 15 lbs regularly and up to 30 lbs on occasion.
Attendance is mandatory. Minimum Qualifications: Master's degree
preferably in Biology or Biochemistry with one (1) year of relevant
laboratory experience; OR, 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 five (5) years' of relevant laboratory experience
AND one (1) year of experience in a GLP/GxP or a comparable
federally regulated environment. Preferred Qualifications: Familiar
with monoclonal antibody testing methodology. Experience in assay
troubleshooting and problem solving. Familiar with Quality Systems.
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 FDBTHRfujifilm.com or call 979-431-3500.
Keywords: FUJIFILM Diosynth Biotechnologies, College Station , Hiring Quality Control Cell Biology Analyst II, Other , College Station, Texas
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