Quality Control Chemist

Quality Control Chemist I (QCC)

Reports to: Quality Control (QC) Management

Responsibilities:

• Perform release, stability, and special request testing of finished products and raw materials following SOPs, in-house test methods, and/or compendial methods.
• Train on the operation of various instrumentation, including but not limited to:
  • Laboratory Balances
  • High Performance Liquid Chromatography (HPLC)
  • Gas Chromatography (GC)
  • Automated Titrators
  • FTIR
  • UV/Vis Spectrophotometer
  • Polarimeter
  • Dissolution and Disintegration Instrumentation
• Stay current on publications from USP, FDA, and other regulating bodies to ensure compliance in analytical applications, release specifications, and documentation practices.
• Assist QC management in resolving Out of Specification (OOS) results and communicate effectively with the Out-of-Specification/Trend Coordinator and Stability Coordinator.
• Assist in training new laboratory personnel and document training.
• Follow cGMP documentation guidelines to record all procedures in a timely fashion.
• Maintain a safe working environment and ensure all equipment used in testing procedures is calibrated and properly maintained.
• Complete specific projects assigned by management and perform other necessary functions.
• Communicate effectively with other departments and function within a team environment.

Minimum Requirements:

• 3–5 years of laboratory experience in a cGMP environment preferred.
• Experience with the operation of laboratory instrumentation, including GC and/or LC, troubleshooting, and the generation and revision of operating procedures and test methods.
• Effective interpersonal and self-motivation skills, with the ability to interact with all levels of personnel.