Senior Analyst 1, QC Chemistry

2 weeks ago


Holly Springs, United States FUJIFILM Corporation Full time
About the Role

The QC Chemistry Senior Analyst 1 plays a critical role in ensuring the quality and integrity of our biological products. This position requires a strong background in analytical chemistry and a keen eye for detail. The successful candidate will be responsible for executing QC analytical chemistry methods, generating analytical results, and identifying laboratory exceptions. This is a challenging and rewarding role that requires strong communication and problem-solving skills.

Key Responsibilities
  • Execute physical and chemical analytical testing methods used in biological product manufacturing, including chromatography, spectroscopy, and electrophoresis.
  • Ensure analytical testing data is captured in LIMS software and data integrity is maintained.
  • Report assay performance and assist with implementing improvements to ensure quality and efficiency within QC Chemistry.
  • Identify and follow up on excursions and deviations, and initiate corrective and preventative actions.
  • Coordinate and support QC Chemistry lab activities as needed.
  • Provide training for QC Chemistry lab associates.
  • Author and review SOPs and technical reports.
Requirements

To be successful in this role, you will need:

  • A B.S. in Chemistry, Biochemistry, Biological Sciences, Engineering, or a related science field.
  • 3+ years of laboratory experience, with 1-3 years of GMP laboratory experience.
  • Experience with physical and chemical analytical testing methods used in biological product manufacturing.
Preferred Requirements

While not required, the following qualifications would be beneficial:

  • M.S. in Chemistry, Biochemistry, Biological Sciences, Engineering, or a related science field.
  • Familiarity with Raw Material methodology as it pertains to cGMP.
  • Experience with LIMS software.
Physical and Work Environment Requirements

This role requires:

  • Ability to discern audible cues.
  • Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
  • Ability to stand for prolonged periods of time up to 240 minutes.
  • Ability to sit for prolonged periods of time up to 240 minutes.
  • Ability to conduct activities using repetitive motions that include writs, hands, and/or fingers.
  • Ability to conduct work that includes moving objects up to 10 pounds.
  • Ability to bend, push or pull, reach to retrieve materials from 18 to 60 in height, and use twisting motions.
  • Ability to work in warm/cold environments.
  • Ability to work in small and/or enclosed spaces.


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