Primary Duties and Responsibilities
• Perform data review and evaluation of the raw data generated by Ardea and/or outside testing laboratories. Data Review will include auditing notebook records for accuracy and compliance with the procedures, checking raw data in respect to materials and equipment, integration of chromatographical data, calculations, data reporting, and etc.
• Will interact with outside testing laboratories and follow up with the release and stability testing schedule, control timely delivery of the analytical data.
• Create and/or review new or existing documents, including test methods, SOPs, analytical validation protocols, and validation reports.
• Create and/or review stability protocols and stability summaries.
• Timely update and follow up with the performance qualification and maintenance schedule of the laboratory equipment. Review, approve, and file all installation/operation/performance qualification data for the laboratory equipment.
• Work closely with chemists to streamline the data review process. Provide feedback and assistance in maintaining GLP and GMP compliance.
• Train new personnel in laboratory systems and compliance.
• May perform other duties, as assigned.
• Bachelor’s (BS) in the Life Sciences or related discipline
• Previous experience with data auditing in QC/QA regulated environment
• Knowledge of GLP and GMP regulations
• Previous laboratory experience and/or theoretical knowledge of chromatography, such as HPLC, GC, etc.
• Previous experience with Empower (implementation and/or use)
• Extensive skills, knowledge and abilities with computers and software programs including Word, and Excel
• High attention to detail, and the ability to work in a fast-paced and team environment.