Quality Control Analyst Data Reviewer
Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: June 23, 2022
Overview Summary: The Quality Control Analyst position, under
general direction, will be responsible for performing review of
routine and non-routine quantitative and qualitative analysis of
samples submitted to the Quality Control (QC) Laboratory. - The
data reviewer is responsible to ensure activities are reviewed in
an efficient and cGMP compliant manner. External US Essential
- Review of QC analytical testing for GMP in-process, release and
stability testing as needed:
- pH, Osmolality, Conductivity & qPCR, RP-HPLC, SEC, Agarose Gel
Electrophoresis, UPLC, CE, IEF, Protein Purity Assays, Peptide
Mapping, DNA Sequencing and/or UV/Vis Spectrometry preferred
- Review technical transfer, qualification and validation
protocols as needed.
- Review laboratory logbooks and equipment logbooks
- Technical Writing to include:
- Writes and revises Standard Operating Procedures (SOPs) and
other Good Manufacturing Practices (GMP) documentation as
- Qualification protocols
- Transfer Protocols
- Creating manuals for processes/activities
- Sample plans (support & edit)
- Assisting and initiating closure of deviations, CAPAs and
- Reviewing Methods for accuracy:
- HPLC, Chromatography (Ion Exchange, SEC, RP-HPLC, Residual
- Reviews data obtained for compliance to specifications and
reports excursion/out of specifications
- Provides OOS investigational support as needed.
- Perform other duties as assigned. -Required Skills & Abilities:
- Ability to review raw data, assess assay and system suitability
- Excellent communication skills.
- Ability to work independently or in a team.
- Ability to follow safety procedures outlined in the Chemical
- 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
- 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:
- Associates degree preferably in Chemistry, Biochemistry, or a
degree in a scientific discipline with 1-2 years of hands on data
review experience, and / or laboratory experience in a GMP or GLP
- Familiar with monoclonal antibody and gene therapy testing
methodologies. - -
- Familiar with Empower Software PlatformWe 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 979-431-3528. -Salary: -
Starting salary will be commensurate with education and experience.
Keywords: FDBT - FUJIFILM Diosynth, College Station , Quality Control Analyst Data Reviewer, Professions , College Station, Texas
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