Sponsor: EMD Millipore
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Medical, Vision, Dental, Short & Long Term Disability, Life, 401k
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.
Bachelor’s Degree in Project Management or Quality Management; Master’s Degree preferred.
Minimum of three years post-graduate experience in a life science/research Quality Control or Quality Assurance laboratory developing operational performance metrics and meeting performance requirements.
Prior experience in a laboratory setting and with general molecular biology techniques.
Experience with a variety of laboratory quality management systems, e.g., GLP, ISO, GMP, and CLIA.
Demonstrated knowledge of one or more of the following topics: consenting patients; collection, processing, storage, and/or shipping of biological specimens; managing and designing databases and inventories; performing data checks; and/or document version control.
Ability to function independently and as a member of a large team; motivate people to achieve excellence; work with multiple leadership and staffing levels and with multiple business units to achieve quality management goals.
Must have excellent communication skills both verbal and written.
Ability to train personnel on quality standards and practices.
Proficient in Microsoft Office Suite, including Word, Excel, SharePoint, Outlook, and Access, with experience with project management software and maintenance and development of electronic databases preferred.
Applicants should please apply at www.vai.org/employment
Van Andel Institute is a nonprofit organization whose mission is to improve the health and enhance the lives of current and future generations through disease research and science education. VAI was founded by Jay and Betty Van Andel in 1996 and is composed of two complementary institutes: Van Andel Research Institute (VARI) and Van Andel Education Institute (VAEI). VARI scientists study the genetic, cellular, and molecular origins of cancer and other diseases and work to translate those findings into effective therapies for patients. VAEI provides a continuum of learning through a variety of educational programs that help to prepare tomorrow’s scientists