This position is for a full time Data Quality Analyst who will be responsible for administrating the day to day implementation and performance of the Quality Management System (QMS) including protocols, tools, and systems for the efficient monitoring, measuring, prevention, and correction of quality deviations. This individual will also develop, implement, communicate, and maintain a quality plan under the leadership of the Director of PBS Operations to bring the VARI for Biospecimen Science’s quality systems and policies into compliance with quality system requirements.
The Program for Biospecimen Science (PBS) serves as the coordinating facility for the prospective collection of biological specimens in West Michigan and as a clearinghouse for the processing, storage, and isolation of analytes to fuel biomedical discovery at VARI and partnering institutions. The PBS also conducts scientific evidence-based practices to advance the field of biospecimen science.
Develop, implement, communicate, and maintain quality plan under the leadership of the PBS Director and the PBS Quality Management Director to bring the VARI Program for Biospecimen Science’s quality systems and policies into compliance with quality system requirements.
Define and maintain QA/QC objectives, targets, and processes and review new targets, protocols, processes, equipment, supplies, and technologies for quality standards in conjunction with the PBS Operations team and PBS leadership.
Assist the Director of PBS Operations in the implementation of the Corrective Action/Preventive Action (CAPA) plan.
Establish QC/QA documentation procedures and monitor QA/QC performance on a variety of systems by gathering relevant data from electronic and hard-copy sources.
Assure proper maintenance and calibration of lab equipment and on-line test instruments.
Perform regular data checks and periodic internal quality audits, recommend changes, and initiate CAPA when appropriate.
Collate and analyze performance data and charts and producing statistical reports.
Identify relevant quality related training needs and deliver training to PBS personnel and associated users and staff.
Provide QMS data, documentation and written components for grants and contracts.
Promote quality achievement and performance improvement throughout PBS.
Establish standards of service for customers and end users.
Maintain a document control and versioning process.
Write technical and management systems reports.
Maintain awareness of the business context and budgetary control issues.
Ensure compliance with national and international standards and legislation.
Auditing internal program operations and sponsored source sites.
Perform all other duties as assigned.