QC Chemist I

PAI Holdings LLCGreenville, SC
1d

About The Position

The primary responsibility of this position is to analyze drug substances, drug products, and/or stability samples using approved laboratory monographs/specifications, Standard Operating Procedures, and USP/NF methodologies to ensure drug products manufactured at and distributed by Pharmaceutical Associates, Inc. meet all quality and compliance requirements.

Requirements

  • BS in Science + 0 years’ experience

Responsibilities

  • Follows all policies, procedures, SOPs, cGMPS, Work Instructions, and supervisor instructions.
  • HPLC/GC Chemists: Shall have an emphasis in HPLC and/or GC methodology and analyses including all applicable preparations (extractions, dissolution, ISE separation, etc.), and training or experience in chromatographic software and instrument troubleshooting.
  • Wet Chemists: Shall have an emphasis in wet chemistry methodology and analyses such as various titrations, dissolution, USP/NF limit tests, Identifications, TLC, etc.
  • Responsible for performing analysis of raw materials, bulk, finished product, and stability samples in a timely and compliant manner, as instructed by QC Supervisor, per applicable SOPs, PAI monographs/specifications, and USP methodology to ensure finished goods are acceptable for distribution.
  • Responsible for documentation of all analyses per applicable SOPs.
  • Responsible for performance of routine laboratory functions to support manufacturing/production and assure that production schedule is met.
  • Responsible for the timely testing and release of manufactured bulk drug products for packaging.
  • Responsible for maintaining clean and organized laboratories. Wash labware and pipettes by loading/unloading dishwasher/pipette washer.
  • Notify Laboratory Coordinator when reagents, standards, and other materials need to be ordered to ensure all resources available for testing.
  • Assist in training and evaluating laboratory personnel to run laboratory equipment for established methods.
  • Assist in documentation review of laboratory notebooks.
  • Accountable for the accuracy and timeliness of work, attention to detail, and adherence to test method monograph/specifications. For following applicable Standard Operating Procedures, including all safety procedures and policies. For working safely in an effective work team.
  • Perform any other related duties as required or assigned.
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