Chemistry Analyst II

Stokes PharmacyMount Laurel Township, NJ
$25Onsite

About The Position

Supports cGMP analytical chemistry analysis associated with processes related to routine testing, stability testing and method transfer.

Requirements

  • Bachelor’s degree in Chemistry or relevant field
  • 3-10 years of experience with HPLC/UPLC analysis, preferably using Empower 3 software
  • Familiar with general laboratory instrumentation and equipment: Karl Fischer, micropipettes, pH meter, analytical balance, vortex, centrifuge, volumetric glassware etc.
  • Familiar with GMPs, FDA, ICH and OSHA requirements
  • Experience using MS word, Excel, and/or relevant applications
  • Must be capable of wearing all protective wear as required by regulations/company standards. This includes, but not limited to; mask, gloves, gown, respirator, safety goggles etc.
  • Must be capable of working with small delicate pieces of machinery to complete appropriate analysis in a timely manner
  • Must be able to work with chemicals used in sample analysis including acids, bases, and solvents following any special safety precautions as required.
  • Must have strong organizational skills and exceptional attention to detail
  • Must exhibit punctuality and low absenteeism
  • Able to work independently, as well as part of a team
  • Able to sit, stand, squat, kneel, reach and walk for prolonged periods of time
  • May need to lift up to twenty-five (25) pounds on occasion

Responsibilities

  • Independently performs analytical testing of
  • Finished Product
  • Research and Development Materials
  • Stability Samples
  • Raw Materials
  • Ensure testing is performed in accordance with cGMP, USP, ICH, FDA and company standards
  • Review and approve analytical testing data
  • Assist investigations
  • Authors/revises SOPs, protocols and data reports
  • Maintains laboratory organization and inventory
  • Assists qualification and calibration of equipment
  • Understand and develop knowledge of FDA regulatory expectations for departmental development.
  • Ensure testing is performed accurately and in accordance with GxP, USP, and company standards.
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