Regulatory Compliance Officer

1 week ago

Greenville, South Carolina, United States HTI Full time
Job Summary

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 meet all quality and compliance requirements.

Key Responsibilities
  • 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.
  • Perform analysis of raw materials, bulk, finished product, and stability samples.
  • Documentation of all analyses.
  • Perform routine laboratory functions to support manufacturing/production.
  • Testing and release of manufactured bulk drug products for packaging.
  • Maintain a clean and organized workspace within the laboratory; wash labware and pipettes.
  • Notify Laboratory Coordinator when reagents, standards, and other materials need to be ordered.
  • Assist in documentation review of laboratory notebooks.
  • Ensure the accuracy and timeliness of work, attention to detail, and adherence to test method monograph/specifications; following applicable SOP's and safety procedures.
Requirements
  • Must have Bachelor's degree in Chemistry, Biology, or Chemical Engineering
  • Must have 1+ year of recent chemistry lab experience.
  • Must have recent HPLC experience. Titration and/or wet chemistry experience is preferred.
  • Strong written and verbal communication skills.
  • Must be authorized to work in the United States without visa sponsorship.
  • Local candidates preferred.

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