Data Review Specialist

• Applies GMP/GLP in all areas of responsibility, as appropriate
• Demonstrate and promote the company vision
• Regular attendance and punctuality
• Read and understand analytical procedures
• Review documentation, generated data, calculated results, and final reports according to departmental, corporate, and client SOPs
• Gain a technical understanding of the techniques in which review is being performed
• Use MS Windows applications such as EXCEL, Word, Access, Outlook email
• Conducts all activities in a safe and efficient manner
• Performs other duties as assigned

Requirements

Master’s degree in a science-related field with 0-2 years of experience in Bio/Pharmaceutical Chemistry drug product/substance testing with knowledge of regulatory requirements.

Theoretical / Practical experience with analytical techniques such as Ligand binding assays, ELISA, RIA, etc. Knowledge of USP/EP compendia, and laboratory software applications such as LIMS, Electronic Notebook is preferred..