QC Chemist

Location: Lancaster, SC

Quality Control Chemist

  • Conduct testing of finished products and raw materials, following Standard Operating Procedures (SOPs), in-house test methods, and/or compendial methods.
  • Support the evaluation of new testing applications and instrumentation, either by developing new methods or adopting compendial methods. Aid in transferring new methods for routine QC use. Assist in ensuring the accuracy, precision, and robustness of methods for testing release samples.
  • Train on the operation of various instrumentation, such as Laboratory Balances, High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Automated Titrators, FTIR, UV/Vis Spectrophotometer, Polarimeter, Dissolution and Disintegration Instrumentation. Will also undergo training on new laboratory test methods when required.
  • Stay updated on publications released by USP, FDA, and other relevant regulatory bodies to ensure compliance in analytical applications, release specifications, and documentation practices within the Quality Control laboratory.
  • Assist in resolving Out of Specification results in the QC Laboratory with the guidance of QC management or designated personnel. Communicate effectively with QC management, the Out-of-Specification/Trend Coordinator, and the Stability Coordinator, as needed.
  • Help in training new laboratory personnel and maintain proper documentation of training in accordance with established laboratory SOPs and training program.
  • Record all procedures in a timely manner, following Current Good Manufacturing Practice (cGMP) documentation guidelines.
  • Maintain a safe working environment and ensure calibration and proper maintenance of equipment used in testing procedures.
  • Execute specific projects assigned by management and perform other necessary functions.
  • Foster effective communication with other departments within the organization and thrive in a team environment.

Requirements:

Minimum of 5-7 years of laboratory experience in a cGMP environment. Preferably, experience in operating laboratory instrumentation, including Gas Chromatography (GC) or Liquid Chromatography (LC), troubleshooting, and generating/revioping operating procedures and test methods.

Education:

Bachelor of Science (B.S.) or Bachelor of Arts (B.A.) degree in a science-related field such as Chemistry, Biochemistry, or Biology is preferred.

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