Quality Control Microbiology Analyst I
Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: January 17, 2022
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
- Assist manufacturing personnel in the identification of
microbiological root cause analysis and provide technical advice as
- Participate in the investigation and review of alert and action
limit investigations as needed..
- Participate in cleaning and process validation activities
- 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
- 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
- Ability to follow safety procedures outlined in the Chemical
- 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
- 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
- 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
- Pharmaceutical or biotechnology industry experience
- Pharmaceutical documentation practices experience
- Experience 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 email FDBTHR@fujifilm.com or call
Keywords: FDBT - FUJIFILM Diosynth, College Station , Quality Control Microbiology Analyst I, Professions , College Station, Texas
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