QC Particulate Scientist II

American RegentShirley, NY
Onsite

About The Position

The QC Particulate Scientist II will demonstrate proficiency in advanced techniques and expertise with particle isolation, manipulation and particle forensics supporting product investigations, process evaluation, examination of customer complaint CRU, source particle characterization and mitigation programs, and R&D container closure studies. This role will also play a supporting role in method development, creation and certification of test sets, and routine analyses for product release by USP <788> & <790>.

Requirements

  • Bachelor’s degree in a scientific discipline required.
  • Minimum of 3 years in a Quality laboratory environment required.
  • Specific vision requirements include 20/40 near vision (can be corrected with eyeglasses or contacts) and color vision.

Nice To Haves

  • Aseptic processing experience preferred.

Responsibilities

  • Tracking/documentation of incoming samples.
  • Prepare laboratory reagents for particulate analysis
  • Operate analytical instruments (ie: SEM/EDS, FTIR, Flow Microscopy)
  • Perform USP <788> & <790> analyses.
  • Perform forensic analysis on unknown particulate samples.
  • Perform verification of sulfur treatment on incoming glass
  • Document all data generated from analyses following GDP.
  • Assist with data entry for analysis and trending.
  • Support the creation and certification of test sets
  • Order and track laboratory supplies.
  • Clean and disinfect laboratory spaces/work areas.
  • Assist in the characterization of particulate matter.
  • Perform routine analysis of final dosage forms and stability samples.
  • Assist in the IQ/OQ/PQ of new laboratory equipment (e.g., new particulate matter systems)
  • Assist in the performance of investigations.
  • Maintain laboratory equipment (e.g., particulate systems, SEM/EDS, FTIR, Flow Microscopy).
  • Perform any other tasks/duties as assigned by management.

Benefits

  • healthcare
  • life insurance
  • profit sharing
  • paid time off
  • matching 401k
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