Responsibilities

·      Assists co-workers and internal customers with interpretation of regulatory requirements (e.g., GLPs), SOP requirements, and other guidance documents, as applicable.

·      Reviews data to ensure quality standards are met and to verify compliance to applicable SOP and regulatory requirements.

·      Maintains working knowledge of client SOPs and requirements as applicable. Ensures that data reviewed meets applicable client SOPs and requirements.

·      Performs regularly scheduled audits of departmental systems and supporting data, as applicable, to ensure proper documentation and maintenance (e.g. training files, client SOP reading lists, logbooks, etc.). 

·      Collects error tracking data for items reviewed and reports trends as feedback to the department.

Education

·      Bachelor of Science/Arts (BS/BA) degree.

Experience

·      Related laboratory, data review, or related experience with a BS/BA degree.