Covance

QC reviewer II BioA

Job Location(s) SG-Singapore
Job Number
2021-78956
Job Category
Quality Assurance
Position Type
Full-Time
Telecommute
No

Job Overview

Ensures that compliance standards are met within the department by reviewing departmental data and reports for accuracy and compliance to applicable Standard Operating Procedures (SOPs) and regulations.  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:
- 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 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

Experience

- Two years of laboratory, data review, or related experience with a BS/BA degree.

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