QC Particulate Lab Techician

American Regent, Inc.•Shirley, NY
•$24 - $25

About The Position

The QC Technician is responsible for routine testing for product release using USP <788>. The role also supports non-destructive (in-vial) particle characterization, method development, routine testing for product release by USP <788> Method 2 for opaque products, particle isolation and manipulation, particle forensics for product investigations, process evaluation, examination of customer complaint CRU, source-particle characterization and mitigation programs, and R&D container closure studies. The position involves tracking and documenting incoming samples; preparing particle-free water; performing USP <788> Methods 1 and 2, Multisizer analysis, and forensic testing of unknown particulate samples; documenting test data; supporting data entry, analysis, and trending; ordering and tracking supplies; cleaning and disinfecting laboratory work areas; characterizing particulate matter; testing final dosage forms and stability samples; supporting qualification of new laboratory equipment; assisting with investigations; and maintaining laboratory equipment. Management may assign additional duties.

Requirements

  • Minimum high school degree.
  • 0–3 years of experience in a Quality Control laboratory environment.
  • Ability to work overtime as needed.
  • Ability to perform the essential duties satisfactorily.

Nice To Haves

  • Aseptic processing experience preferred.

Responsibilities

  • Track and document incoming samples.
  • Prepare particle-free water for particulate analysis.
  • Perform USP <788> Methods 1 and 2.
  • Perform Multisizer analysis.
  • Perform forensic testing on unknown particulate samples.
  • Document all data generated from testing.
  • Assist with data entry for analysis and trending.
  • Order and track laboratory supplies.
  • Clean and disinfect laboratory spaces and work areas.
  • Assist in the characterization of particulate matter.
  • Perform routine testing of final dosage forms and stability samples.
  • Assist with IQ/OQ/PQ of new laboratory equipment, such as particulate matter systems.
  • Assist in the performance of investigations.
  • Maintain laboratory equipment, including particulate systems, sonicator, and laminar flow hoods.
  • Perform other tasks and duties as assigned by management.

Benefits

  • Healthcare
  • Life insurance
  • Profit sharing
  • Paid time off
  • Matching 401(k)
  • A wide range of other benefits
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