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Duties and 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 with 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.).
- Collect error tracking data for items reviewed and reports trends as feedback to the department.
- Monitors citation trends 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.
- Complete self-development opportunities.
- Performs other related duties as assigned.
Requirements:
- Bachelor of Science/Arts (BS/BA) degree.
- Ability to efficiently use basic software (e.g., Word, Excel, PowerPoint).
- Preferably with good knowledge of ligand binding assay and GxP experience.
- 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
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Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
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