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Minimum of 5+ years of progressive Quality experience working in regulated environment preferably in the field of biotechnology, biopharma, and/or cell/gene therapy (deep experience with GLP or GCP preferred.
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Review and approve Lab Events, Deviation, or OOS related to Product Test Data Packages from CTL/CMO. Own change controls, quality events, and CAPAs related to product testing events per company procedures.
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As a Quality Development Manager, you will contribute to the development of high quality, robust InterSystems HealthShare software by working hard to uncover weaknesses and areas for improvement.
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The Manager will oversee GCP activities across various areas of development, ensuring compliance, and quality execution of clinical trials. Our Clinical Quality team is growing, and we are currently recruiting for a Manager/Sr. Manager of GCP Clinical Quality Assurance.
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The Data Manager will evaluate how digital governance of research data impacts data quality and will work to maximize the value of analytics and innovation to transform the university’s data reporting capabilities, while encouraging the adoption of contemporary methods, practices, and measurement outcomes, producing consistent and accurate information.
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The lab manager creates systems to monitor data quality and performance. The Quality Control Manager will ensure the QC laboratories are set up to support production and the stability program while ensuring that data results from the lab are accurate and precise.
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Minimum Requirements: Requires a BS in health administration, nursing, or a related clinical field; 4 years of health care quality or data analysis experience; or any combination of education and experience, which would provide an equivalent background.
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Coordinate with Program Leads, Biostatistics, Data Management, Medical Affairs, Pharmacovigilance to develop/implement Phase appropriate procedures to ensure consistency and quality with respect to Clinical Trial support activities.
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The selected candidate will also work collaboratively with Quality Assurance to assess laboratory conformance with cGMPs, and with CMC Regulatory Affairs to ensure the translational accuracy and integrity of data incorporated into Module 3 sections of CTD regulatory submissions and written responses to regulatory authorities.
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Kelly Science is seeking a Quality Assurance Manager for a client located near Burlington, MA. Minimum of 5+ years of progressive Quality experience working in regulated environment preferably in the field of biotechnology, biopharma, and/or cell/gene therapy.
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Maintains working knowledge of the National Trauma Data Standard (NTDS) and American College of Surgeons Trauma Quality Improvement Program (TQIP) data definitions and serves as a resource to the data coordinator team.
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Develop, implement, and maintain Food Safety and Quality SOP's, Food Safety Plan/HACCP, GMP's, pest control, allergen control, Good Laboratory Practices, Traceability, Recall, and other applicable food safety/quality programs.
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Advanced knowledge in the management of quality events and GCP deviations, inclusive of conducting robust root cause analysis and developing CAPA plans that mitigate risks to the company, to safety and data integrity.
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Provide proactive GCP QA support for clinical development to ensure patient safety, data integrity, compliance, and operational excellence. 5+ years of direct GCP pharmaceutical/biotechnology experience in Clinical Quality Assurance.
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Report data related to the health of the DMS and LMS to Senior Executive Team via the Quality Management Review. We are seeking a Senior Manager/Associate Director, Quality Assurance, Systems, Training and Document Control to join our team.
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data quality jobs Title: quality manager in Watertown, MA
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