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Experience in small molecule drug substance and solid oral dose production and development, packaging/labeling/serialization, third-party logistics, and supporting continuous clinical trial medicine supplies.
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By unlocking the information present in microbial cell-free DNA, we're helping doctors quickly solve their most challenging cases, providing industry partners with access to the microbial landscape to accelerate biomarker discovery and clinical trials, discover novel microbes, to ultimately reduce patient suffering worldwide.
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In 2019, we expanded into Milpitas, CA for non-clinical production and in 2022, completed our cGMP patient specific cancer vaccine peptide production facility. We are seeking a qualified individual to join us as the Manager of Quality Assurance at our Menlo Park facility.
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The candidate will be reporting to VP of Quality Assurance and is responsible for the strategic development and management of QA operations to support CMC operations and clinical activities in compliance with FDA, ICH, EMA regulations, guidances, industry standards, and company policies.
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Reporting to the Executive Director, Clinical Quality Assurance, the Associate Director/Director, Clinical Quality Assurance will define and support the quality oversight and management of GCP activities internally at BBGT (and other affiliates as directed) and externally with BBGT vendors, consultants, and service providers, including, but not limited to, quality systems management, document review, and approval.
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Title: Manager/Senior Manager, Quality AssuranceReports To: Associate Director, Quality Assurance Operations Location: Redwood City, California Classification: Exempt Overview:The Manager/Senior Manager, Quality Assurance, represents the quality organization at Coherus and at Contract Manufacturing Organizations (CMOs) to ensure appropriate oversight/monitoring of production, and ensure continuous supply of clinical and commercial products.
$110,000 - $170,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Q Bio’s clinical digital twin platform, Gemini, is the first to capture and monitor comprehensive baseline patient health in a scalable virtual model. We're revolutionizing primary care with the first clinical digital twin platform, powered by breakthrough whole-body scanning technology, that highlights the most important changes in a person’s physiology for sharing with physicians and specialists anywhere in the world.
$160,000 - $200,000 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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With its foundations in engineering disciplines, the company's platforms vertically integrate proprietary hardware, software, bioinformatics, chemistries, and molecular biology to advance basic research, target validation, and clinical trials.
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Interact with key stakeholders such as Formulation and Process Development, Manufacturing, Engineering, Packaging, and Regulatory Affairs to ensure that Commercial / Clinical Drug Products are manufactured in accordance with established procedures, cGMPs, and to appropriate regulations.
$99,790 - $129,140Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Glooko is the Unified Platform for Diabetes Management and provides an FDcleared, HIPAcompliant Web and Mobile (iOS and Android) application for people with diabetes, the clinicians who treat them, and those conducting clinical research on diabetes treatment.
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Element Science, Inc. is a medical device and digital health company focused on developing solutions at the intersection of clinical-grade wearables, machine learning algorithms, and lifesaving therapies in order to address leading causes of death and hospitalization in patients with heart disease, primarily as they transition from the hospital-to-home.
$140,000 - $150,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Provide Clinical Quality Assurance (GCP) leadership and Subject Matter Expertise (SME) to clinical study teams. Minimum of 8 years of experience in a GCP practice area; Clinical Quality Assurance or similar role preferred.
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Expertise in Quality Systems and cGMP standards applicable to method validation for clinical and commercial products and AO/QC laboratory operations. Reviews and approves method validation and/or transfer documents, including protocols, reports, methods, change controls, and specifications for small molecules and/or large biologics for analytical operations and contract labs/manufacturers across the clinical and commercial supply chains.
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Collaborate closely with R&D, Manufacturing, Regulatory Affairs, Clinical, HR and other departments to integrate quality into all aspects of product development and manufacturing. Minimum of 10 years of progressive quality assurance experience in the medical device, electrosurgical industries (Class II, Class III, or PMA.
$215,000 - $228,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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The candidate will also work closely with Head of Clinical Development to develop the long-term global regulatory strategy and vision for our cell therapy products in development. TriArm Therapeutics is a clinical-stage biotechnology company that is advancing CAR T cellular therapy with novel platforms that are designed for enhanced safety, efficacy, and accessibility compared to conventional autologous CAR T therapies.
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clinical job Title: assurance in San Carlos, CA
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