Xyntek Inc.
Compliance Specialist
Xyntek Inc., Fremont, California, us, 94537
Fremont, United States
| Posted on 11/01/2024Catalyx specializes in the science of operational processes. With a footprint across North America and Europe, the company carefully automates and services R&D, production, packaging, and delivery processes—globally—with a sophisticated blend of products, technologies, and lifecycle services. The company was formed in 2022 after CXV Global (Crest Solutions, Xyntek, and VistaLink) and Panacea Technologies joined forces. For over three decades, Catalyx’s partnership-based culture has helped organizations in production-intense, highly regulated industries optimize their operational efficiency, performance, and safety. To learn more about the company's experience and comprehensive suite of capabilities and solutions, visit www.catalyx.ai.Job Description
Individual contributor responsible to manage change control records and lead projects in support of Manufacturing Operations. This position will support in the monitoring, reporting of deviations, change controls and improvement projects. This position is responsible to own and change control records, CAPAs and Periodic Review documents and SOP revisions.Helps to identify areas for Continuous Process Improvement and applies operational excellence tools to reduce process variability and steadily deliver measurable efficiency gains.Skills
Possesses knowledge in the area of manufacturing bio-pharmaceuticals.Has experience in managing simple to moderate projects, and CAPA.Possesses knowledge of cGMP systems and of regulations from different regional jurisdictions. Has some knowledge of change controls, deviations, project management, and audits/inspections.Some experience leading meetings, and mastery of some techniques to keep meetings effective and team on task.Projects are cross-functional and the project scope is limited. The specialist should be able to independently influence peers to achieve a common goal.Experience writing technically (e.g. SOPs or protocols, or deviations, etc.)Must be able to multi-task and be organized.Experience in biotech, pharmaceutical manufacturing is a requirement.Preferably experience being a manufacturing operator or technician.Education
Bachelors Degree with a focus on Bio-pharmaceuticals.
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| Posted on 11/01/2024Catalyx specializes in the science of operational processes. With a footprint across North America and Europe, the company carefully automates and services R&D, production, packaging, and delivery processes—globally—with a sophisticated blend of products, technologies, and lifecycle services. The company was formed in 2022 after CXV Global (Crest Solutions, Xyntek, and VistaLink) and Panacea Technologies joined forces. For over three decades, Catalyx’s partnership-based culture has helped organizations in production-intense, highly regulated industries optimize their operational efficiency, performance, and safety. To learn more about the company's experience and comprehensive suite of capabilities and solutions, visit www.catalyx.ai.Job Description
Individual contributor responsible to manage change control records and lead projects in support of Manufacturing Operations. This position will support in the monitoring, reporting of deviations, change controls and improvement projects. This position is responsible to own and change control records, CAPAs and Periodic Review documents and SOP revisions.Helps to identify areas for Continuous Process Improvement and applies operational excellence tools to reduce process variability and steadily deliver measurable efficiency gains.Skills
Possesses knowledge in the area of manufacturing bio-pharmaceuticals.Has experience in managing simple to moderate projects, and CAPA.Possesses knowledge of cGMP systems and of regulations from different regional jurisdictions. Has some knowledge of change controls, deviations, project management, and audits/inspections.Some experience leading meetings, and mastery of some techniques to keep meetings effective and team on task.Projects are cross-functional and the project scope is limited. The specialist should be able to independently influence peers to achieve a common goal.Experience writing technically (e.g. SOPs or protocols, or deviations, etc.)Must be able to multi-task and be organized.Experience in biotech, pharmaceutical manufacturing is a requirement.Preferably experience being a manufacturing operator or technician.Education
Bachelors Degree with a focus on Bio-pharmaceuticals.
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