Katalyst Healthcares & Life Sciences in United States
153 jobs at Katalyst Healthcares & Life Sciences in United States
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QC Engineer III
1 week ago
Katalyst Healthcares & Life Sciences Creve Coeur, United StatesResponsibilities: · Assume site level responsibility for all investigations originating from Quality Control Laboratory and Stability group. · Perform root cause analysis (RCA) · Facilitate cross functional teams to evaluate causal factors · Provide a complete and thorough in ...
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Senior Business Analyst
5 days ago
Katalyst HealthCares & Life Sciences South Plainfield, United StatesSenior Business Analyst – Global Patient Safety - Pharmacovigilance · Department: Pharmacovigilance · Job Summary: As a Senior Business Analyst within the Pharmacovigilance group at our client you will play a key role in ensuring the effectiveness and efficiency of our drug safet ...
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Validation Expert
1 week ago
Katalyst HealthCares & Life Sciences Boston, United StatesResponsibilities: · Understand and able to review vendor Qualification document package in line with regulatory requirements. · Knowledge of System and Functional Risk assessment / management, defining risk mitigation plan. · Should have good Stakeholder management skills to i ...
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Quality Engineer
3 days ago
Katalyst HealthCares & Life Sciences Buena Park, United StatesResponsibilities: · Test Method Validation and Process Validation in support of design transfer and production transfer. · Measurement System Analysis (MSA) & Gage R&R (repeatability & reproducibility) · Process risk documentation, including updates to PFMEAs. · Team communic ...
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CSV Engineer
20 hours ago
Katalyst Healthcares & Life Sciences Raritan, United StatesResponsibilities: 3+ years' Experience in Validating MES or Manufacturing an Lab systems. Experienced in CSV activities in Manufacturing related applications like SAP Systems, MES systems or Lab related systems in the manufacturing space. Perform review for GxP systems to ensure ...
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Manufacturing Engineer
2 days ago
Katalyst HealthCares & Life Sciences Raynham, United StatesResponsibilities: · 2-5 years of experience in manufacturing and/or process engineering. · Development of specifications and user requirements for new equipment that supports manufacturing operations · Planning, development, and execution of equipment/process qualifications as ...
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Senior Validation Engineer
3 days ago
Katalyst HealthCares & Life Sciences Parsippany, United StatesResponsibilities: · Lead and manage multiple commissioning / qualification / validation activities performed at facility with minimal supervision. · Equipment Qualification / Re-Qualification (IQ, OQ, PQ) for process equipment, QC equipment, packaging equipment, clean utilities ...
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Validation Engineer
12 hours ago
Katalyst HealthCares & Life Sciences Indianapolis, United StatesResponsibilities: · Determine project scope and strategy with client groups and other stakeholders to execute small and large capital projects in a cGMP environment. · Participate in the development of the following Validation efforts: Validation Planning, Protocol Generation, ...
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Manufacturing Engineer
1 day ago
Katalyst HealthCares & Life Sciences Arlington Heights, United StatesResponsibilities: · Lead new product introductions and ensure successful transition to manufacturing · Provide manufacturing engineering support for the development and manufacturing of new products · Evaluate proposed designs for manufacturability and provide DFM recommendati ...
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Design Quality Engineer
1 day ago
Katalyst HealthCares & Life Sciences San Jose, United StatesResponsibilities: · Working knowledge of CFR 21 820, ISO 13485, ISO 14971, IEC 10993, IEC 60601 standards and ROHAS/REACH compliance · Implementation GD&T and tolerance analysis in mechanical design outputs · ASQ QE, Lead Auditor certifications preferred · Must be detail orie ...
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Clinical Trails Manager
3 days ago
Katalyst HealthCares & Life Sciences Cincinnati, United StatesResponsibilities Manage and provide accountability for day-to-day operations of the project, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and regulations · Serve as primary Sponsor contact for operational project-specific issues and ...
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Equipment Validation Engineer
2 days ago
Katalyst HealthCares & Life Sciences Los Angeles, United StatesResponsibilities: The candidate should have expertise in (verification) testing, systems and methods qualification & validation, and maintenance of Laboratory Equipment · Experience designing validation protocols for Equipment Validation, including IQ/OQ/PQ and reports is requi ...
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Quality Specialist
4 days ago
Katalyst HealthCares & Life Sciences Boston, United StatesResponsibilities: Advocates and leads design for manufacture and assembly through technical leadership and direction in quality assurance, quality control and preventative activities. · Supports the development and introduction of new products, processes, and technologies, with ...
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Statistical programmer
2 days ago
Katalyst HealthCares & Life Sciences New York, United StatesResponsibilities: A statistical programmer consultant provides timely support to the study team on all programming matters according to the project strategies. · Requirements will be identified according to a Statistical Analysis Plan and programming specifications using interna ...
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Operator 2, Warehouse Operation
1 week ago
Katalyst HealthCares & Life Sciences Four Oaks, United StatesResponsibilities: Load and off-load inbound and outbound shipments utilizing the WMS. · Report discrepancies between the inventory count and shipping/receiving documents. · Ensure every effort is made to load/off-load pallets in a manner that promotes safety and impedes damage. ...
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Quality Manager
1 day ago
Katalyst HealthCares & Life Sciences Flower Mound, United StatesResponsibilities: · Develop, execute, and analyze quality-reporting measures. Report to management on quality issues, trends and losses. Managing monthly KPI reports for all PDC's. · Develop and manage production procedures and processes to ensure effectiveness and efficiency. ...
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Spec 2, Complaint Mgmt
2 days ago
Katalyst HealthCares & Life Sciences Sparks, United StatesResponsibilities: Communicating with distributors to collect customer information. · Conducting all administrative activities such as faxing, mailing, and filing of recall notifications. · Maintaining customer information. · Facilitating the replacement process with customer ...
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QA Validation Specialist
1 day ago
Katalyst HealthCares & Life Sciences Boston, United StatesResponsibilities: · Develops understanding of regulations pertaining to the implementation and use of computerized systems in GCP / GMP areas. · Participates in system implementation project teams to provide guidance on System Lifecycle activities and validation strategy to be ...
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Validation Engineer,packaging
12 hours ago
Katalyst HealthCares & Life Sciences South Plainfield, United StatesRoles&Responsibilities: · Pack Bay 3 will be repurposed to be a dedicated line for the packaging of autoinjector devices for client WCS-081. The new packaging line will be utilizing equipment from the existing line as well as bringing in new equipment. The existing equipment tha ...
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Validation Engineer
1 day ago
Katalyst HealthCares & Life Sciences Arlington, United StatesResponsibilities: · Background from Quality Mazaak i200 and EMC Oven Machine Validation. · Acts as a resource to work groups and project teams, within the plant and outside the plant relative to quality and validation related activities. · Need to have familiarity with manufac ...