in engineering, LifeSciences, Chemistry, or a related field. 7–8 years of hands-on experience in instrument validation in regulated...
Responsibilities: Collect, compile, organize, and analyze data from multiple sources, simultaneously for review by commercial, legal, and OEC management. Maintain outstanding level of oral and written communication when addressing daily ...
Responsibilities: Plan and execute experiments based on bioanalytical protocol and in vivo study design. Analyze pre-clinical in vivo samples based on operational schedule. Qualify ligand binding assay based on bioanalysis protocol, int...
/ quality assurance for lifesciences company regulated by the FDA is preferred. Advanced level experience in design of user... products. Provides QA oversight on key software development life cycle (SDLC) processes such as problem, incident, change...
Responsibilities: Ensure design verification and validation activities meet regulatory requirements. Support new product development and sustaining engineering projects, ensuring compliance with FDA QSR, ISO 13485, and ISO 14971. Collab...
Responsibilities: The consultant will provide programming/analytical support utilizing client as the primary programming language to create and manage the production of analysis reports. summary tables/listings and graphs for clinical tr...
Responsibilities: Monitor system dashboards and alerts for infrastructure and batch processing. Perform initial troubleshooting and checks;escalate unresolved issues using ServiceNow. Document issues and responses to alerts within the ...
Responsibilities: Ability to consistently produce high quality histological slides. Recognize variations in tissue specimens. Knowledge of chemical rationale of staining procedures. Understand and adhere to corporate standards regardin...
Responsibilities: Review protocols and comply with study-specific activities that impact telemetry areas of responsibility. Communicates in an appropriate and professional manner with study subjects and unit personnel. Maintain accurate...
Responsibilities and Requirements: The position is at Roche Branchburg, NJ, Start date: Mid Jan / beginning of Feb. They need to be good protocol authors, good communicators, and can draft, review and execute qualification protocols on p...