Microbiology Analyst I
Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: January 10, 2021
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Job Description:
Overview Summary: The Microbiology Analyst I will be responsible
for assisting the QC microbiological aspects of cGMP compliance and
testing at the FujiFilm Biotechnologies Diosynth Texas (FDBT)
Quality Control Laboratory. External US Essential Functions:*
Assist with QC microbiological aspects of cGMP compliance and
testing.* Assist manufacturing personnel in the identification of
microbiological root cause analysis and provide technical advice as
needed.* Participate in the investigation and review of alert and
action limit investigations as needed..* Participate in cleaning
and process validation activities involving microbiology.* Assist
in the investigation of microbiological data deviation results and
PRs. * Assist in creating and revising microbiological Standard
Operating Procedures (SOPs) and other current Good Manufacturing
Practices (cGMP) documentation.* Assist in scheduling of monitoring
procedures with follow-up responsibility to assist with providing
test results.* Assist in the 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.*
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 30 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;
OR* Associate of Science degree preferably in Biochemistry,
Chemistry, Biology or related field with two (2) years of relevant
experience.Preferred Qualifications:* Pharmaceutical or
biotechnology industry experience* Pharmaceutical documentation
practices experienceExperience in a GLP/GxP or comparable federally
regulated environment.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 , Microbiology Analyst I, Professions , College Station, Texas
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