- Teleflex (Wyomissing, PA)
- …instructions, verification protocols and reports, laboratory reports (LRs), and other design control documentation . - Contribute to and lead CAPAs, NC ... in design control processes, agile systems, and creation of design documentation . - Solid knowledge of regulatory and quality standards (FDA 21 CFR Part… more
- Teleflex (Wyomissing, PA)
- …document retrieval and DMR navigation for change execution. - Contribute to documentation accuracy for change control processes including engineering drawings ... improvements. This role assists in implementing product changes, developing technical documentation , and participating in labeling, CAPA, and system activities. The… more
- Organon & Co. (Plymouth Meeting, PA)
- …identification?of?global?regulatory requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential ... the development, authoring and review of CMC submission components and documentation to support post-approval supplements, annual reports, registration renewals and… more
- Organon & Co. (Plymouth Meeting, PA)
- …of global regulatory requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks. + ... the development, authoring and review of CMC submission components and documentation to support post-approval supplements, annual reports, registration renewals and… more
- AeroVironment (Pottstown, PA)
- …assembly drawings, and weldment drawings + Demonstrated understanding of industry design & documentation standards (GD&T, ASME, Change Control , etc.) + Hands on ... engineering change orders, bills of materials, and other related engineering documentation . The Designer/Drafter works with engineers and manufacturing personnel to… more
- Talen Energy (Allentown, PA)
- …Compliance which Includes maintaining NERC procedures and logs and other required documentation . + NERC EACMS (Electronic Access Control or Monitoring Systems) ... are cyber assets that perform electronic access control or monitoring for the Bulk Electric System (BES) Cyber Systems or Electronic Security Perimeters. + Maintain… more
- Parexel (Harrisburg, PA)
- …through nextGen portals is a plus - Ensure audit readiness and version control through meticulous documentation and system management Qualifications Experience & ... regulatory guidance in collaboration with global regulatory leads Submission & Documentation Excellence - Prepare, coordinate, and review CMC and GMP-related… more
- Eisai, Inc (Exton, PA)
- …the process performance, assist troubleshooting, and adhere to GMP documentation ensuring compliance to relevant regulations. The Sr. Manufacturing Technician ... timely reporting, investigation, and resolution of manufacturing deviations, change control , and corrective/preventive actions. Participate in root-cause analysis and… more
- Teleflex (Wyomissing, PA)
- …to bring innovative catheter solutions from concept to commercialization using design control processes. You could participate in all technical phases of product ... 3D models, 2D drawings, simulation models, statistical design transfer functions, and design documentation . - Build and test prototypes in the lab using a variety of… more
- Carnegie Mellon University (Pittsburgh, PA)
- …prepare briefings for regular reviews and status updates. + Own document control for SOPs, checklists, and acceptance criteria; enforce versioning, approvals, and ... competence-procurement, inventory, vendor management, instrument maintenance/calibration, safety/EH&S compliance-plus disciplined documentation (SOPs, checklists, versioned data) + Clear written/oral communication… more
