- Lilly (Indianapolis, IN)
- …and other key partners to deliver standardized data collection methods and innovative validation solutions for use in global clinical trials. **This is a hybrid ... of applicable internal, external and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA , ICH, GCP, PhRMA, Privacy knowledge, etc.) to study build work… more
- Unither Pharmaceuticals (Rochester, NY)
- …and sterility highly desired. Experience in design of experiments, method validation , and production environments desired. Computer Skills: Ability to ... approving laboratory data. Maintains instruments and equipment. Coordinate the validation and calibration of laboratory instrumentation. Laboratory SME Support… more
- Cordis (Irvine, CA)
- …+ Develop, and qualify new tooling and equipment. + Verification and validation of processes, machines, and equipment to meet requirements of Company procedures. ... * Ability to make independent decisions * Knowledge of validation verification process, Gage R&R, and a clear understanding...verification process, Gage R&R, and a clear understanding of FDA 's QSR and GMP * Basic proficiency in SolidWorks… more
- GE HealthCare (Bellevue, WA)
- …a decision. **Required Qualifications** + Minimum of Bachelor's Degree in Engineering, Computer Science or equivalent. + Minimum 5 years' experience in Quality ... Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485. Demonstrated expertise to effectively communicate… more
- Cedars-Sinai (Los Angeles, CA)
- …and work with bioinformatics to develop and maintain trial management and validation systems. Ensures compliance with all federal and local agencies including the ... Food and Drug Administration ( FDA ) and local Institutional Review Board. **Primary Duties and...development and maintenance of clinical trials management systems including validation of systems, as needed. + Train clinical research… more
- Cardinal Health (Indianapolis, IN)
- … validation , and/or transfer protocols, analytical equipment qualification protocols, or computer system validation test scripts, as needed. + Performs ... of relevant work experience working with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device) preferred. + Has experience in authoring… more
- Lilly (Indianapolis, IN)
- …IT support to end-users and addressing their needs promptly. + Maintain computer system validation for responsible applications. + Deliver recommendations to ... time-sensitive situations. **Basic Requirements:** + Bachelor's degree in Software Engineering, Computer Science, Computer Engineering, or a related field. +… more
- Guidehouse (Mclean, VA)
- …cleaning, data transfers, data quality control, data integration and validation , data analysis and report package preparation, statistical simulation, statistical ... biology, biochemistry, microbiology or similar), or physical science (engineering, physics, computer science, or similar) + **OR** **Post graduate degree in**… more
- Cardinal Health (Phoenix, AZ)
- …electrical, mechanical, and control domains. + Develops detailed 3D CAD ( Computer Aided Design) models, engineering drawings, and assembly documentation. + ... senior engineers. + Participates in prototype fabrication and testing, using CNC ( Computer Numerical Control) machining and additive manufacturing tools as needed. +… more
- ThermoFisher Scientific (Greenville, NC)
- …sites. + Performs data review as specified in the client contract and data validation manual including review of coding listings and/or full safety data to assess ... detail, process and prioritize sensitive complex information + Proficiency in basic computer applications + Fluent in spoken and written English + Excellent… more