QC Chemist II, QC

Location
Morris Plains
Salary
See job description.
Posted
March 23 2021
Ref
R0018274
Position Type
Full Time
Organization Type
Pharma
Job Type
Technician

Essential Duties and Job Functions:
  • Executes biochemical and chemistry release and stability testing using CE-SDS and icIEF following written procedures and applicable SOPs. Reports data in a GMP compliant manner.
  • Supports in-process, release, and stability testing using routine analytical techniques such as capillary electrophoresis, as well as concentration analysis by A280 as needed, based on laboratory demand.
  • Participates in validation and technical transfer of analytical methods commensurate with experience.
  • Performs timely and accurate peer review of analytical test results.
  • Performs preventative maintenance and/or calibration activities or coordinates and schedules these activities with a third-party provider.
  • Responsible for cleanliness and orderliness of work area, maintains the laboratory in a state of inspection readiness and performs other laboratory maintenance duties as assigned.
  • Participates in continuous improvement initiatives; looks for ways to improve compliance or efficiency and communicates to management.
  • Participates in laboratory investigations and root cause assessment.


Essential Education, Experience and Skills:
  • Bachelor's Degree and a minimum of 3 years of applicable GMP laboratory experience is required.
  • Experience using analytical techniques such as capillary electrophoresis and UV spectrophotometry.
  • Ability to exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining results.
  • Excellent oral and written communication, organizational, and interpersonal skills with ability to multitask while working under restrictive timelines.
  • Ability to work in a team environment and perform job responsibilities with minimal supervision.
  • Knowledge with analytical methods currently used for purity and impurities testing for release and stability of biopharmaceutical products.
  • Fluency in Empower, Windows, and Microsoft Office.



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