QC reviewer

Position Overview:

Reviews study data for accuracy and compliance with appropriate SOPs, regulations (e.g. GLPs) and client requirements. Maintains and expands knowledge of regulatory requirements, SOP requirements, and other guidance documents. Maintains and communicates error tracking data in support of departmental improvement efforts. Participate in the process optimization and employee training etc.

Duties and Responsibilities:

Reviews all types of study data to ensure meet quality standards and compliance with applicable SOPs, regulations (e.g. GLPs) and client requirements.

Maintains and seeks to expand a strong working knowledge of regulatory requirements (e.g. GLPs), SOP requirements, and other guidance documents. Applies existing knowledge to data review or training tasks.

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

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

Monitors error trend and performs follow-up actions with respondents, management, or others, if needed, to prevent recurring problems, or errors.

Participates in quality improvement opportunities and harmonization efforts to promote best practices.

Participates in internal employees training and acts as a mentor for new employees.

Performs other related duties as assigned.

Education Requirements:

Master of Science (MS) degree plus at least 2-year applicable experience.

Bachelor of Science (BS) degree plus at least 4-year applicable experience.

The degree can be in Chemistry, Biology or related field.