Quality Review Specialist
We have a great opportunity for aQuality Review Specialist on our Methods Development Team in Chantilly, VA.
Lapcorp Drug Development's work in developing new pharmaceutical solutions has an incredible impact on millions of lives worldwide. Be a part of this life-saving work and help improve patients' lives while growing your career.
In this role, you will review data for accuracy and compliance to applicable Standard Operating Procedures (SOPs) and regulations. Maintains and expands knowledge of regulatory requirements, SOP requirements, and client requirements. Performs follow up actions to reduce departmental citations in eQA as needed. Maintains error tracking data in support of departmental improvement efforts.
Duties and Responsibilities:
- Assists co-workers and internal customers with interpretation and understanding 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 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 tasks.
- Maintains a working knowledge of client SOPs and requirements. Applies knowledge to data review tasks.
- Collects error tracking data for items reviewed.
- Monitors citation trends in eQA and performs follow-up actions with respondents, management, or others, if needed, to prevent recurring citations, problems, or errors.
- Completes self-development opportunities.
- Performs other related duties as assigned.
- Bachelor of Science/Arts (BS/BA) degree.
- Ability to efficiently use basic software (e.g., Word, Excel, PowerPoint).
- Experience may be substituted for education. For example, a two-year Associate degree plus 2 years applicable experience may be substituted for a BS/BA degree
- One year of laboratory, data review, or related experience with a BS/BA degree.
Labcorp is proud to be an Equal Opportunity Employer:
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