- Trane Technologies (Noblesville, IN)
- …as needed. Ensure that device history records (DHR) are completed according to FDA GMP requirements. + Complete nonconformance records according to established ... procedures and GMP requirements. + Required to do limited amounts of wiring or foam for packaging based on business need. + Sheet Metal Assembly (using various… more
- AbbVie (Worcester, MA)
- …and/or renovation of biopharmaceutical process equipment, facilities, and utilities in an FDA / GMP regulated environment. The engineer will work in a ... prioritization, technical, mechanical, and communication skills as well as experience in a GMP environment are preferred + Must be able to work independently with… more
- Trane Technologies (Noblesville, IN)
- …as needed. Ensure that device history records are completed according to FDA GMP requirements. Complete nonconformance records according to established ... procedures and GMP requirements. . Troubleshoot equipment failures. . Various assembly activities. . Train new employees by demonstrating work. This role has been… more
- System One (Irvine, CA)
- …years of manufacturing experience with 7-10 years in a management role + FDA GMP regulation experience + Requires breadth of organizational, professional field ... device manufacturer, is seeking a hands-on change agent to lead operations at a GMP -regulated site-with future potential to step into a Site General Manager role. If… more
- ThermoFisher Scientific (Fremont, CA)
- …regulatory compliance for medical devices or diagnostics. + Strong technical skills in FDA , GMP , ISO 13485 compliance, process improvement, and development. + ... lbs. without assistance, Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Some… more
- Novo Nordisk (Bloomington, IN)
- …team, including operational protocol development, to implement compliance with FDA GMP requirements + Identify improvements and efficiencies ... the degree required + A minimum of 2 years of experience working in a GMP environment in the pharmaceutical or medical device industry is required; 5 years of… more
- Trane Technologies (Noblesville, IN)
- …as needed. Ensure that device history records (DHR) are completed according to FDA GMP requirements. + Complete nonconformance records according to established ... procedures and GMP requirements. + Sheet Metal Assembly (using various assembly tools). + Follows work instruction to determine the process required. + Train new… more
- ThermoFisher Scientific (Greenville, NC)
- …Knowledge** : Familiarity with relevant industry standards and regulations (eg, ISO, FDA , GMP ) is highly desirable. + **Certifications** : Relevant ... of 5-7 years of experience in quality assurance in a pharmaceutical or similar GMP environment, with at least 3 years in a quality validation role. + **Technical… more
- Tecomet (Lansing, MI)
- …detail: High level of precision and accuracy required in measurements. + Regulations - FDA , GMP and ISO. + Microsoft office (Word, Excel, Outlook, PowerPoint). ... quality within medical device manufacturing industry preferred + ISO 13485, FDA 820 and customer interaction experience preferred **Knowledge, Skills, and… more
- Abbott (Minnetonka, MN)
- …team member leading a CAPA project + Use of quality tools/methodologies. Detailed knowledge of FDA , GMP , ISO 13485, and ISO 14971 + Risk management, post market ... requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes,… more