The Spray Auditor will provide technical support for routine data integration and reviewing activities of raw materials, finished product, bulk in-process and component documentation. Identify basic technical problems, a typical test results or methodology and assist in the investigation to correct them. Remediate complicated technical issues related to the collection of data. Other important duties include ensuring notebooks and reports are in compliance with regulatory guidelines, completing projects’ data review within time limits, and verifying mathematical calculations, interpreting results, recording observations and responding to and assisting in audits and investigations.
• Accurately review data using validated test methods and SOPs in a cGMP environment.
• Demonstrate technical competence in the data review that is related analytical data integration. Review methods that is related to use of instrumentation & data processing to the job including, but not limited to:
o HPLC High Pressure Liquid Chromatography
o UPLC Ultra High Pressure Liquid Chromatography
o IR Infra-Red Spectroscopy
o Spray Characterization Tests
o Particulate Matter Tests
• Support regulatory submission information gathering.
• Identify opportunities to improve processes/systems.
• Responsible for analyzing data, maintaining accurate and detailed written records and notebooks and thoroughly reviewing lab notebooks ensuring compliance to test methods and specifications.
• Perform testing within the lab, when necessary.
• Perform other duties and responsibilities as assigned such as Trackwise deviation initiation.
Bachelor’s degree required. Master’s degree preferred. A minimum of 5 years of HPLC or UPLC experience in pharmaceutical industry required.