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The Manager / Senior Manager, GMP Quality Control will work closely with cross-functional teams to assess, monitor, and enhance quality systems, ensuring that all GMP data adhere to relevant regulatory requirements.
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This includes performing analytical methods, data review and trending, and implementation of GMP operational support systems ensuring a compliant Quality Control lab. resilience.com Position Summary: We seek an experienced Analyst, QC Bioassay / Biochemistry to support establishing new commercial-level in-house GMP testing laboratories performing release and stability testing for multiple stages of our gene therapy and immune oncology products.
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Fulfill role as SQF Practitioner (both food safety and quality), HACCP coordinator, and PCQI in compliance with FDA Food Safety Modernization Act. The Quality Manager supports the Sugar Cone and Cake Cone production facilities at the Hermitage, PA location to facilitate and maintain the food safety and quality programs in coordination with Production, Warehouse, Maintenance, Procurement, and Sanitation departments.
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Expected to adhere to safe work practices, follow GMP and HACCP guidelines, maintain sanitary conditions and ensure that product quality is maintained in order to maintain SQF certification.
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Job Description: The Supplier Quality Manager-Sr Manager is responsible for management of systems and processes supporting Altimmune's oversight of its GMP suppliers. The selected candidate will have a detailed understanding of manufacturing processes, tech transfer, analytical testing, quality systems and GMP requirements for drug products and combination products.
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Expected to adhere to safe work practices, follow GMP and HACCP guidelines, maintain sanitary conditions and ensure that product quality is maintained in order to maintain SQF Level 3 certification.
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Previous experience using GMP Quality Systems (ex. Quality Control Scientist IV , demonstrates full understanding of scientific and technical aspects of biological Drug Product/ Drug Substance (DP/DS), as well as technology transfer, assay qualifications and validations activities.
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Comprehensive knowledge of biologic and drug development process, pharmaceutical technology, manufacturing processes, GMP, quality assurance & management and related issues, preferably in the areas of cell and gene therapy.
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5+ years’ experience in GMP Quality or Manufacturing in biopharma/biologics/pharma industry. – Provide guidance, advice, and support for GMP quality and compliance. We are looking for a Manager/Senior Manager of Quality Operations to help provide quality oversight for our biologics commercial and clinical development programs.
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You will have demonstrated experience, leadership, and independence with QC functions associated with the GMP production and testing of cell/gene therapy products or biologics in both clinical and/or commercial settings.
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QA compliance manager, quality assurance, QA, management, GxP, GCP, GLP, GMP, auditing, clinical research, regulatory, inspections, sponsor audits, stakeholder management, process improvement, travel, investigator site audits, TMF audits, QMS, communication, remote, united states, US.
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This individual will join the Quality Control leadership team supporting the GMP manufacturing facilities in Redmond, WA and Seattle, WA. As the QC Stability and Sample Management Manager, you will be responsible for the daily oversight for the QC stability and sample management operations in support of routine GMP operations at Just-Evotec.
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Demonstrated background in support of GMP Quality management systems, The Quality Specialist II provides support to the overall Quality Assurance program at the site. Contributes to the development, implementation and execution of quality systems programs, as required.
$80,000 - $81,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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This individual will join the Quality Control Bioassay team supporting the GMP manufacturing facilities in Redmond, WA and Seattle, WA. The role is responsible for conducting routine/non-routine testing and analysis of GMP product using methods such as ELISAs, qPCR, and cell-based assays at both Washington state facilities.
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Most of all, The Roaster must be passionate about making a high quality great tasting coffee. Must develop knowledge of GMP, SQF, food plant operations and safety. Participate in blending and weighing roasted coffee while maintaining great quality and adhering to visual standards set forth by La Colombe.
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