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The company is widely regarded as a leader in providing business consulting, systems integration and ongoing support services focused on Content Services and its applicability to business-critical solutions including RIM, Regulatory, Clinical and QMS. fme is partnered with the leading Business Solutions and ECM vendors supporting the Life sciences industry, including Veeva Vault, OpenText Documentum, Generis CARA, Honeywell TrackWise and TrackWise Digital, and Alfresco.
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The ideal candidate will deeply understand SQL Data base, Windchill Application, including PDMLink, MPMLink, QMS, ProjectLink, and various other modules. Profound knowledge in Windchill PDMLink, MPMLink, QMS, ProjectLink, Options and Variant Module, and Partslink Classification.
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Duties carried out in accordance with the HistoWiz QMS and Standard Operating Procedures (SOPs) to support GLP and non-GLP work. HistoWiz has over 1,000 paying customers globally from top academic institutions (e.g. MSKCC, Harvard, Stanford, HHMI) and pharmaceutical companies (e.g. CRISPR, Johnson & Johnson, Regeneron.
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Develop, implement, and maintain the pharmaceutical quality management system (QMS) to ensure compliance with regulatory requirements (e.g., FDA, EMA), industry standards (e.g., cGMP), and company policies.
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Your key responsibilities Your time will be spent managing projects and engagement teams on the following project types: Implementation of QMS, DMS, VLMS, Safety, LIMS, and RIM systems (e.g. Veeva, Trackwise, ValGenesis, Kneat, EtQ Reliance, Argus, Calyx) as a workstream lead for Quality, regulatory, laboratory, Pharmacovigilance, and clinical business processes.
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Reporting on QMS/business process performance and opportunities for improvement to management. Ensuring the maintenance of the integrity of the QMS/ business process when changes are planned and implemented.
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The auditor must have strong QMS/GMP Auditing experience having conducted many Supplier or External audits throughout his or her career. SQA manages Supplier Audit and Supplier Development programs for customers in many industries including Pharmaceutical, Medical Device, Automotive, Aerospace, and Electronics manufacturing.
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Minimum of 5 years of experience as a Developer/Business Systems Analyst with a focus on QMS in the medical device industry, including expertise in Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions.
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Maintain a clear understanding the specific components that affect each component of the 5 Star rating system to attain favorable outcomes data for all short-stay and long-stay QMS, including overall Star rating and changes to both state and federal regulations.
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Manage training program, including training plans/schedules, cGMP, new hire QMS overview. Act as the primary business owner/administrator for the QMS system and fulfills the duties of the Management Representative.
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Seven -plus years of experience in a regulatory role having oversite to compliance and involvement in QMS in the nutrition and dietary supplement categories. Master’s degree in a scientific field is required with emphasis on regulatory affairs and in the dietary supplements category.
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Certification on Veeva Vault Administration is a must; Certification on at least 2 functional Veeva areas is preferred, e.g., Veeva CTMS, QMS etc. like IoT, Gen AI, AI-ML2, Data Analytics, Robotics, Blockchain, AR/VR, Veeva, IQVIA, Salesforce etc.
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Adheres to Integer’s Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
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Understanding of Medical Device QMS and design control, familiar with PDM/PLM system and change control process. Ensure all the design activities and documents meet the regulatory and QMS requirements.
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Provide training for key Corporate QMS processes, including Corrective and Preventative Actions (CAPA), Change Control, Complaint Management, and Supplier Quality. Promote Quality Awareness and Employee Engagement in the QMS.
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qms job in Long Island City, NY
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