The purpose of this role is to apply basic knowledge of principles/theories and concepts to develop solutions to technical problems of limited scope and to perform basic tests and analysis in the Quality Control Analytical Chemistry Laboratory. This role will conduct laboratory procedures in compliance with established protocols while keeping appropriate records, providing information to other departments/clients.

Provide technical support for routine testing activities and conduct physical and chemical analysis of samples, products and materials. Primarily responsible for technical transfer and validation of methods to support quality control testing of products and materials. Identify basic technical problems, atypical test results or methodology malfunctions and assist in the investigation to correct them. Other important duties include ensuring notebooks and reports are in compliance with regulatory guidelines, completing projects within time limits and budgetary constraints, performing mathematical calculations, interpreting results, recording observations and responding to and assisting in audits and investigations. Participate in departmental training and provide guidance to junior staff members.

The individual will be responsible for the following laboratory activities:

• Accurately generate data using validated test methods and SOPs in a cGMP environment.
• Demonstrate technical competence in the use of wet chemical techniques and instrumentation pertinent to the job including:
  • IR Infra-Red Spectroscopy
  • UV/Vis Ultra Violet/Visible Spectroscopy
  • GC Gas Chromatography
  • HPLC High Pressure Liquid Chromatography
  • UPLC Ultra High Pressure Liquid Chromatography
  • AA Atomic Absorption Spectroscopy
  • Dissolution apparatus
• Compendial testing (USP EP, FCC) – ex. Monograph assay, limits tests, chemical and physical tests
• Tests chemical components or products using major laboratory instruments such as HPLC, GC, FTIR, UV-VIS spectrophotometer, pH meter, viscometer, etc.
• Notifies laboratory supervisor when OOS results are obtained and may assist with gathering data and documentation of notifications in Trackwise.
• Performs quality control testing of media, reagents, and identification materials.
• Maintains adequate inventory of media and materials required for testing.
• Notifies laboratory supervisor when OOS results are obtained; may assist with gathering data and documentation of notifications in TrackWise.
• Assists in revising SOPs or methods.
• Responsible for the general use of quality systems (e.g. Trackwise, Documentum, LIMs, etc.)
• Assists in troubleshooting instrument or method issues.
• Assists with investigations.
• Provides thorough documentation in laboratory notebooks, ensuring compliance to test methods and specifications.
• Ability to work in a team environment.
• May assist with training less experienced employees.
• Maintain training logs to comply with current SOP requirements.
• Ensuring safety regulations are adhered to in the laboratory.

Qualifications:

• Bachelor of Science Degree in Chemistry, Biology or related science
• 0-2+ years experience in cGMP analytical laboratory