- Aequor (Fort Worth, TX)
- …monitoring for production. Conducts and analyzes in-process and final product quality analyses/ inspection in compliance with standards and regulatory ... Job Description: Job title: Associate I, Quality Control Lab - Microbiology Location: Fort Worth,...requirements Identifies on-going quality issues, prevents potential production issues and makes suggestions… more
- Repligen (Clifton Park, NY)
- …SOPs and safety proceduresresponsible for area cleanlinessread and understand quality and inspection documentsread/understand molding drawingsbasic math ... role Medical supplies or manufacturing experience is a huge plus. Quality control or inspection experience is highly...experience is a huge plus. Quality control or inspection experience is highly desirablePrevious experience working in a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Quality Manual into an annual Quality Plan, including quality risk assessments and inspection readiness components for designated programs.Ensure ... Affairs QA is responsible for providing strategic leadership and comprehensive quality oversight across all Medical Affairs programs. This role involves deputizing… more
- Eisai, Inc (Nutley, NJ)
- …responsible for design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and ... make a difference. If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is… more
- Repligen (Waltham, MA)
- OverviewWe are seeking a Supplier Quality Engineer to join our growing Supplier Quality team. You will a key role in ensuring the quality , compliance, and ... collaborative professionals responsible for managing supplier qualification, risk mitigation, and quality performance. The team plays a key role in driving supplier… more
- Insmed Incorporated (San Diego, CA)
- …and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance, the Director of Clinical Quality Assurance (CQA) ... serves as a strategic leader managing quality and regulatory compliance related to GCPs,...therapy products is preferred.Experience with effectively managing regulatory agency inspection and working with regulators and internal staff to… more
- Aequor (Fort Worth, TX)
- …in support of production at the Aspex Manufacturing site. Responsible for the inspection and disposition of raw materials, packaging components, and parts in support ... of production at the ASPEX Manufacturing site. Maintain QC Analytical Laboratory in compliance with regulatory standards and site procedures. Document and Review Analytical Data and Laboratory records accurately, in a timely manner, and completely. Conduct lab… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of continuous improvement in benefit-risk evaluation, and participate in inspection readiness activities.Responsibilities:This individual will be the main point of ... as instruct teams on how to properly conduct high quality clinical evaluation of signals in the appropriate tool...a global and regional level as required.Support audit and inspection readiness activities as a subject matter expert. This… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …multiple myeloma.Legend Biotech is seeking QA Investigations Lead I as part of the Quality team based in Raritan, NJ. Role OverviewThe QA Investigation Lead is an ... Investigation Excellence Team. The QA Investigations Lead is responsible for providing quality oversight and guidance during the investigation of events that occur… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …team, responsible for ensuring adherence to regulatory requirements and internal quality standards across cell and gene therapy manufacturing processes. This role ... analysis, impact assessment, and CAPA/EC determination.Work cross functionally with SME's and Quality to ensure robustness of investigations, as well as accuracy and… more
