Katalyst CRO Jobs in United States

Familiar with pharmaceutical master batch records and authoring CMC submissions for clinical studies. · Filing necessary applications and handling government interactions pertaining to the regulation process. · Authoring and submitting PMA supplements. · ...

Validar y mantener sistemas empresariales basados en la nube, incluyendo Oracle Fusion Cloud ERP y serialization platforms. Implementar e validar sistemas de registro electrónico (EBR) como MasterControl. Apoyar la validación del sistema de serialización para envíos completos de ...

Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical trials. · ...

+We are seeking an experienced Project Manager with a strong background in medical device component development and New Product Development (NPD). · ...

We are seeking a Techno-Functional Specialist with strong expertise in Labware LIMS Development with GxP-compliant process awareness and hands-on experience in ServiceNow. · ...

This position involves assembling and manufacturing medical devices. · ...

Manufacturing and assembling clinical and commercial products. · ...

Sr. CSV Engineer responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution. · ...

Lead and manage clinical data management activities for oncology clinical trials ensuring adherence to project timelines budgets and quality standards. · ...

Data integrity specialist responsible for implementing and maintaining data integrity controls for HPLC systems in compliance with ALCOA+ principles and regulatory standards. · ...

Creates Computer System Validation (CSV) deliverables and collaborates with teams to define validation requirements and plans. · ...

The Operational Excellence Engineer Intern will provide support to the OpEx Engineering team to help drive the Lean transformation and quality improvement initiatives in manufacturing by ensuring strategies are implemented and principles/practices/tools are incorporated into the ...

This is a 6-month contract with the possibility for extension or conversion. The ideal candidate will have proven experience in quality engineering within the medical device sector and demonstrate the ability to work independently. · Oversee quality activities to ensure complianc ...

5+ years of CQV experience focused on utilities, process equipment and process validation. Strong documentation experience across CQV lifecycle deliverables including URS/FRS risk assessments protocols summary reports deviations trace matrices Excellent technical writing and comm ...

+Job summary · We're looking for a Regulatory Affairs Consultant to join us and help drive and support our growing regulatory function. · +ResponsibilitiesWe're looking for a Regulatory Affairs Consultant to join us and help drive and support our growing regulatory function. · Yo ...

The MES Quality Engineer II position will work closely with the IT, Operations, Validation, and Engineering teams to ensure that projects related to MES are implemented compliantly and in a timely manner. · Bachelor's degree (4 years) or higher from an accredited course of study ...

Validation engineer providing validation experience and guidance during equipment design and qualification phases of a project. · Provide input to address validation deviations and/or change requests. · Create validation summary reports. · ...

Responsibilities · Real-time Inspection Readiness. · Develop, manage and contribute to ongoing maturity of GMP and GDP Inspection Readiness Plans associated with regulatory filings and real-time inspection readiness activities. · Work directly with CMOs and the Company Manufact ...

5+ years of experience as a Validation Professional with strong knowledge of FDA, EMA and GxP regulatory requirements. · ...

A minimum of 8 years' work experience in GXP / Analytical lab environment. · Bullet points for responsibilities and requirements are omitted to provide a concise summary. ...