- Daiichi Sankyo, Inc. (Bernards, NJ)
- …reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to programming ... reports, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements.Oversees the execution of external… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the drug development process.- Collaborates within the function and cross-functionally to resolve issues pertaining to data management in clinical trials and ... to ensure data quality /integrity and regulatory compliance- Ensures that Data Management Plans are consistent and regulatory compliant across studies and… more
- Aequor (San Diego, CA)
- …conversant in concepts and techniques related to software development and data management .Demonstrated ability to plan and organize effectively across ... requirements.Collaborate with peers across Acadia on procedures relating to quality , data integrity and computer system validation.Primary… more
- Merck & Co. (Durham, NC)
- … Assurance (QA), Quality Assurance (QA) Standards, Quality Assurance Tools, Quality Auditing, Quality Management Systems (QMS), Quality Risk ... run reconciliation activities as required (ie, UV and FIT testing).Perform Quality retain sample management activities.Lead housekeeping and self-inspections.May… more
- Formation Bio (New York, NY)
- …the product development lifecycle. Ensure the timely and effective resolution of quality issues and deviations, working collaboratively with internal and ... and sites, providing support during health authority inspections, and offering guidance on quality issues . Ensuring vendors adhere to relevant quality … more
- Merck & Co. (Rahway, NJ)
- …Compliance (IC), and Policy, Licensing and Evaluation (PEL).Develop and maintain global Quality Management System (QMS) documents pertaining to USDA requirements ... GMP Auditing, GMP Compliance, GMP Operations, Good Manufacturing Practices (GMP), Inspection Readiness, Quality Auditing, Quality Management , Quality … more
- Merck & Co. (Durham, NC)
- …Performance Improvement Plans, Pharmaceutical Manufacturing, Pharmaceutical Quality Assurance, Quality Assurance (QA), Quality Control Management , ... Job DescriptionQuality Assurance Associate SpecialistOur Quality Assurance group ensures every single material inside our products is manufactured, processed,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …their expectations. Quality Assurance Provides secondary support to all USO Quality Management processes, including but not limited to Product Disposition ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR... management of contingent workers. Essential Functions Deviation Management Acts in role of Quality Assurance… more
- Eisai, Inc (Nutley, NJ)
- …and inspection management , issue management and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) ... inspection management , issue management , and oversight of the quality management system).Conduct complex audits of sites, vendors and internal… more
- Aequor (Irvine, CA)
- …continuity and product conformance. Leads investigations into production and customer-facing quality issues to identify root cause, implement corrective and ... Description: The Quality Engineer is responsible for maintaining quality...variety of audiences within the organization Proficient in project management , data analysis, root cause analysis, communication,… more
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