- Work for the best Central Laboratory services in the world
- Dynamic and collaborative team, with supportive leadership
- Competitive compensation and benefit
Role at a Glance:
The role ensures that compliance and scientific standards are met within the department by reviewing departmental data for scientific integrity and compliance to applicable Standard Operating Procedures (SOPs) and regulations. Initiates and facilitates quality improvement objectives throughout the department. Monitors departmental systems and trends in eQA and performs follow up actions as needed. Maintains and communicates error tracking data in support of departmental improvement efforts.
Duties and Responsibilities:
- Takes a lead role in guiding co-workers and internal customers with interpretation of regulatory requirements (e.g., GLPs), SOP requirements, and other guidance documents, as applicable.
- Possesses a strong understanding of departmental processes and acts as a consultant for improving compliance within the department.
- Reviews data to ensure that quality standards are met and to verify compliance to applicable SOP and regulatory requirements. Utilizes scientific judgment to ensure scientific soundness and integrity of data reviewed.
- Maintains working knowledge of client SOPs and requirements as applicable. Ensures that data meet applicable client SOPs and requirements.
- Independently schedules and performs 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 and guides quality improvement opportunities and optimization efforts to promote best practices.
- Participates in project debrief meetings or client visits as needed.
- Facilitates changes to SOPs, policies, training materials, and other documents as applicable.
- Mentors less experienced QC staff.
- Completes self-development opportunities.
- Performs other related duties as assigned.
- Interacts internally with operations personnel, scientific personnel, and departmental management. May interact with internal Covance QA. May interact with external clients.