Job Description: This position is responsible for the successful implementation and coordination of equipment and facilities validation programs in compliance to cGMPs, FDA requirements and company policy. Development and execution of equi...
Job Description: The Quantitative, Translational ADME Sciences (QTAS) department at client is seeking a highly...
Responsibilities: Lead the development, validation, and documentation of CDISC-compliant SDTM and ADaM datasets for CNS clinical trials, ensuring traceability from raw data through analysis outputs. Program and QC tables, listings, and f...
Job Description: Equipment Validation Specialist exists to ensure all critical GMP equipment and systems are validated and maintained in compliance with user requirements, process parameters and global regulatory guidelines. The role provi...
Responsibilities: The delivery of regulatory guidance to project teams and external partners is a key activity that assists the company in achieving its business goals. The incumbent will serve as a member of the Global Regulatory departm...
Job Description: We are looking for an experienced Senior Lab Instrument Support Engineer (Equipment Validation Engineer) to support GxP-regulated analytical laboratories across NJ and PA. This is a hands-on, onsite role for a professional...
Job Description: Carries out the practical work in the laboratory including method development, method validation and trouble shooting. Takes over responsibility for the QC part of projects. Perform required testing on raw materials, inter...
Job Summary: Seeking a Manufacturing Engineer with medical device experience to support and improve manufacturing processes in a regulated environment. Roles & Responsibilities: Develop and optimize manufacturing processes Support...
Job Description: Reports directly to Engineering Manager or reports to Production Supervisor. Performs routine set up, operation, minor and major routine maintenance, preventative maintenance (PM) and troubleshooting of highly complex/auto...
, and management of the clinical study database throughout its life cycle, from CRF design, database development and testing...