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The QA Test Manager will manage and participate in the creation of complex test scenarios & data sets, conduct workflow analysis, and maintain comprehensive test assets, including test scripts, results, and defects.
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The BEST QA Test Manager plays a critical role in ensuring the quality and compliance of the software solution with Commonwealth functional and technical requirements. Trillium Professional is now seeking a Quality Assurance Test Manager in Boston.
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Conduct QA in the company’s programs, including ensuring Data Integrity in processes, data packages and reports to the Company’s external pharma and gene therapy partners. 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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The QA Test Manager plays a critical role in ensuring the quality and compliance of the software solution with the client's functional and technical requirements. Assist in testing of interfaces, data conversion, performance, load, backup, and recovery.
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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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Provide hands-on leadership for the QC Operations oversight of the group, data review, schedule and training. Experience in data management, LIMS experience preferred. Ensures appropriate data integrity controls/ALCOA/data integrity issues for system requirements.
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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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Provide proactive GCP QA support for clinical development to ensure patient safety, data integrity, compliance, and operational excellence. The Manager will oversee GCP activities across various areas of development, ensuring compliance, and quality execution of clinical trials.
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The BEST QA Test Manager plays a critical role in ensuring the quality and compliance of the software solution with. Position Title: Quality Assurance test Manager. Support iterative testing of data conversion scripts and files.
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Assist in establishing processes to ensure Data Integrity and communicate the principles of data integrity for GLP/GCP. BostonGene is seeking a Clinical Quality Manager to join our Quality Assurance team.
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An understanding in the interpretation of Department of Health and Human services and FDA regulations and experience in clinical research monitoring and data management analytic methods in a health care setting necessary.
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Our cloud-first data platforms solve interoperability, speed, and scalability problems for organizations around the globe. InterSystems also develops and supports data management in hospitals through the world’s most proven electronic medical record, as well as unified care records for health systems and governments through a powerful suite of healthcare data integration solutions.
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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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Manage domestic and international audits of sites, documents, databases, vendors or internal systems in compliance with GCP and Takeda policies and procedures; assess impact of audit findings on subject safety, data integrity, and business operations.
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Manages collection of aggregate data from adverse event reports, claims and loss prevention strategies, for identification of corrective and preventive actions. Identifies trends and collaborates with clinical teams to design strategies to prevent medical error and reduce loss.c. Provides feedback to safety reporters regarding investigations and corrective actions resulting from adverse event reports, as appropriate.d. Reviews and evaluates aggregate adverse events and claims data, as well as other hospital information in order to identify high-risk activities, procedures and departments.e. Recommends corrective and preventive actions to reduce risk.
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data job Title: quality manager in Somerville, MA
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