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.
• Monitors citation trends in eQA and performs follow-up actions with respondents, management, or others, if needed, to prevent recurring citations, problems, or errors.
• Promotes quality and regulatory compliance within the department by working with operations and scientific staff to resolve service/quality issues, serving on a committee, assisting with the development of training programs related to documentation and quality, or other related involvement.
• Notifies management of observed quality/compliance issues and service failures.
• Participates in quality improvement opportunities and harmonization efforts to promote best practices.
• Participates in project debrief meetings as needed.
• Facilitates changes to SOPs, policies, training materials, and other documents as applicable.
• Completes self-development opportunities.
• Performs other related duties as assigned

Requirements:

• Bachelor of Science/Arts (BS/BA) degree.
• Min. 2 years of laboratory, data review, or related experience.
• Ability to efficiently use basic software (e.g., Word, Excel, PowerPoint).