職位描述
Responsibilities / Duties:
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.
Education / Qualifications
Bachelor of Science/Arts (BS/BA) degree.
Ability to efficiently use basic software (e.g., Word, Excel, PowerPoint).
Experience
Two years of laboratory, data review, or related experience with a BS/BA degree.
