Quality Control Chemist

Quality Control / Lab Durham, North Carolina


Description

  1. Perform assigned sampling, physical, chemical tests and assay on raw materials, active pharmaceutical ingredients, in-process, finished and stability products, using various wet chemicals, physical and instrumental techniques (HPLC, GC, UV-Vis, IR, Particle Size Analyzer, NGI cascade impactor, KF Auto titrator, Bulk Density, and other routine QC instruments)  as per as per USP monograph / In-house / any other Compendial monographs.
  2. Work with supervisor to plan and make adequate inventory of test reagents and solutions to perform work, assure supplies are ordered as needed to perform assigned work.
  3. Work with supervisor to plan and execute testing to meet established time lines. Perform complicated testing with supervisory direction.
  4. Record data and results as specified in documentation procedures. Document work clearly and perform tests accurately.
  5. Prepare and/or Review Test Procedures, SOPs, and Protocols as assigned.
  6. Perform maintenance and calibrations of laboratory instruments/equipment with supervisory direction/training as needed.
  7. Perform troubleshooting and investigations under the direction of a supervisor.
  8. Comply with all regulatory/in-house requirements (may include but not limited to safety, house keeping, laboratory  chemical waste, cGMP, cGLP, documentation) when performing the assigned activity.
  9. Review of Analytical documents as required
  10. Perform other duties as assigned

QUALIFICATIONS
  • BS or MS in Chemistry, Pharmaceutical Sciences, or related field is preferable
  • Minimum 5-10 years of experience in pharmaceuticals and must have 5 + years of experience in Analytical testing
  • 5+ years QC experience in Generic Pharmaceutical industries would be preferable
  • Experience in a cGMP environment is required
  • Experience with dermatological, transdermal, and/or inhaled dosage forms is preferable
  • Knowledge and use of Good Documentation practices
  • Knowledge of USP/ICH/FDA guidelines
  • Ability to learn quickly and having decision making skills