Katalyst CRO Jobs in United States

This position will work as an interface between the supplier and Customer plant sourcing, supplier quality and inspection areas. · ...

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

+Job summary · The Senior CQV Engineer is responsible for leading and executing Commissioning, Qualification, and Validation (CQV) activities with a strong focus on CIP systems supporting Drug Substance Manufacturing.ResponsibilitiesCQV & Validation ExecutionLead and execute comm ...

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. · ...

This role is responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process and sustaining engineering projects. · ...

+The Senior Quality Engineer is responsible to represent the quality engineering function to develop and execute the strategy to organize, direct, and report on all supplier quality-related activities for design and manufactured items made for the AST stapling business platform.+ ...

We are seeking to add top talent to our Materials Support team. The Material Handler performs operations of the Supply Chain/Materials Management department with awareness and knowledge of the various areas of the operations in Goods Receipt, Goods Issue, Warehousing, · Inventory ...

Plan lead execute validation efforts SCADA Rockwell Factory Talk PLCs Ignition Talk Create write validation documentation VP URS FS DS Trace Matrix Risk Assessment IQ OQ PQ etc author documents related GxP Systems Draft Requirements computer systems validation documents using GAM ...

This role involves design changes for medical device products such as hospital beds and equipment. · ...

Plans and leads Design Verification projects as a technical contributor cum project leader. · ...

The Senior Validation Engineer will serve as a subject matter expert in validation · This role involves strategic planning execution and continuous improvement of validation processes across multiple sites while supporting audits risk assessments and global quality initiatives. · ...

Ensure proper integration and support of quality regulations: drug, biologics, device and/or combination products. · Assist project teams in planning, preparation, review and approval of quality documentation. · Implement and maintain the effectiveness of the quality system for d ...

Responsibilities include value stream assessment and process design. · ...

This role is responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process and sustaining engineering projects ensuring compliance with FDA and EU regulations ISO standards and other regulatory agencies. · ...

Carries out the practical work in the laboratory including method development and trouble shooting. · ...

We are seeking an experienced professional to manage and support Waters Empower Chromatography Data System (CDS), oversee laboratory instrument integration, perform troubleshooting, and ensure system compliance with GxP and 21 CFR Part 11 regulatory requirements. · Manage user ac ...

Project Manager roles and responsibilities include US project management experience and preferable experiences on medical devices operations manufacturing supply chain. · ...

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 ...

Job SummaryThe Sr. Product Quality Engineer will serve as a technical representative providing design quality expertise to a product development team. · Maintaining a strong collaborative partnership with cross-functional team members to achieve patient/user safety, customer sati ...

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 ...