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Participate and contribute in the validation maintenance, re-qualification of upstream (cell culture and harvest) production equipment. The Upstream Manufacturing Specialist of Upstream Operations will be responsible for hand-on executing the routine operation, maintenance, and periodically requalification of cell culture based upstream production equipment and production suites in a cGMP biopharmaceutical pilot plant.
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We have the capabilities to analyze virtually any peptide, protein or antibody, and have built a reputation for solving technical challenges related to assay development and validation. Directly participates in the delivery of broader research efforts by acting as a flexible resource, supporting other functional areas and providing scientific input (e.g. assist Assay Development, Validation and troubleshooting, Assay Transfers.
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Participate and contribute to the validation, maintenance, and requalification of upstream (cell culture and harvest) production equipment - 5% Under the direct supervision and guidance of senior staff, the Upstream Operations Process Technician will play a hands-on role in the routine operation, maintenance, and periodic requalification of cell culture-based upstream production equipment and production suites in a cGMP biopharmaceutical pilot plant.
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Provide CQV (commissioning, qualification, and validation) support for our new manufacturing facility. Responsible for Project Validation Master Plans (PVMP), Commissioning Test Plans (CTP), IQ/OQ/PQ protocols, Environmental Monitoring PQ protocols, summary reports.
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The Metrologist provides cGMP analytical laboratory equipment calibration and qualification support, including drafting and execution qualification/validation protocols, instrument calibration, maintenance, and decommissioning.
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Supports in cross-functional activities, such as engineering actions, validation actions and Tech Transfer actions, including proactive safety and compliance input prior to execution. OR an Associate's degree from Montgomery county community college in Biotechnology or related technical field with cGMP manufacturing experience.
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The QA Validation Manager/Sr. Manager is responsible for the oversight and implementation of the Marken Quality Management System (QMS), Marken Standard Operating Procedures (SOPs), processes, and policies required to manage validation life cycles, calibration and maintenance of equipment/facilities used in support of Marken's global storage, distribution, and logistics operations.
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Conduct validation activities for computerized systems, with a focus on Emerson DeltaV distributed control systems and Syncade manufacturing execution systems. As a Validation Engineer at Valspec, you will play a crucial role in ensuring the compliance and reliability of our clients' computer systems, particularly those utilizing Emerson technology.
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Provides quality support within the Pilot Plant in the execution of key quality systems, including equipment, system, and utility validation, SIP, Autoclave, and on-going process improvementefforts.
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Responsibilities Review of Biologics bioanalytical data (notebook documentation, raw data, and LIMS data) for accuracy, consistency, and completeness to ensure compliance with SOPs and GLP. Review method development/qualification/validation reports and sample analysis reports including text and data for accuracy and consistency.
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12 monthsLocation: Exton, PAAs a Quality Analyst, your responsibilities:Description: The QC Analyst 2 will contribute to the success of the operation by providing accurate, GxP-compliant analyses of clinical biopharmaceutical products and by participating in assay qualification and validation studies.
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You will be joining a small cyber security team of about 3 people and will have the opportunity to collaborate closely with the CISO. The primary responsibilities of this role include project-related tasks such as validation, CrowdStrike, incident response, and Cloud Security.
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Experience in dealing with sensitive data protection testing, security testing and report generation validation. We at Coforge are seeking Senior Quality Assurance Analyst with below mentioned skill-set and who can work onsite from Oaks, PA location (Hybrid basis) Role: Senior Quality Assurance Analyst Location: Oaks, PA Mode Of Hire: Full Time Key Skills: API Testing, UI Automation Framework, Selenium, TestComplete, Postman, TestNG, Jira and Agile.
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Perform data analysis and transfer using Watson LIMS, and assist in preparation of assay validation report or sample analysis report. Conduct method validation and sample analysis in a regulated environment, including but not limited to planning assay runs in Watson LIMS, performing the assay, and summarizing data.
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Provides quality assurance support of validation, manufacturing, and testing of clinical trials materials and serves as a quality assurance resource for the Pilot Plant staff. Provides review of technical, validation and other protocols and reports, with emphasis on adherence to quality systems, and with FDA, EMEA, ICH and JP regulations/guidance.
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validation job Company: 3si Security in Malvern, PA
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