Quality Control Microbiology Analyst IV
Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: September 24, 2022
Overview Summary: The Microbiology IV will demonstrate a strong
technical background and be responsible for the QC microbiological
aspects of cGMP compliance and testing at the FujiFilm
Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory.
External US Essential Functions:
- Responsible for QC microbiological aspects of cGMP compliance
- Perform microbiological validations as needed for finished
product and in process controls and buffers.
- Serve as SME for one or more of the functional streams: utility
monitoring, environmental monitoring or material monitoring.
- Assist manufacturing personnel in the identification of
microbiological root cause analysis and provide technical advice as
- Lead the investigation and review of alert and action limit
investigations as needed and implements corrective action as
- Lead the cleaning and process validation activities involving
- Lead the investigation of microbiological data deviations and
- Prepare technical proposals, amendments, reports and
- Develop and/or contribute toward creating and revising
microbiological Standard Operating Procedures (SOPs) and other
current Good Manufacturing Practices (cGMP) documentation.
- Schedule monitoring procedures with follow-up responsibility to
provide test results.
- Review EM and product release data.
- Maintain active communication with other relevant groups
including but not limited to Quality Assurance, Manufacturing and
- Participate in internal assessments and regulatory audits as
- Lead training and problem-solving initiatives internally and
- Ensure lab is maintained (organized, clean, properly
- Evaluate new Microbiology methods and equipment.
- Prepare Quarterly trend reports and other trend reports as
- 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:
- Master's degree preferably in Biochemistry, Chemistry, Biology
or related field with three (3) years of relevant experience; OR
- Bachelor's degree preferably in Biochemistry, Chemistry,
Biology or related field with five (5) years of relevant
- AND 3 years' industry experience in a GMP / GxP or a 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 or call .
Keywords: FDBT - FUJIFILM Diosynth, College Station , Quality Control Microbiology Analyst IV, Professions , College Station, Texas
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