- Jabil (Hunt Valley, MD)
- …major and/or experience working in a regulated life-science. . Strong understanding of FDA 's Six- System Audit Schema . Ability to effectively present information ... customers, and other entities as it pertains to Pii's Systems and Processes. . Ability to define problems, collect...valid conclusions. . Advanced skill to operate a personal computer including using a Windows based operating system… more
- BioFire Diagnostics, LLC. (Hazelwood, MO)
- …With engineering centers in the United States, France, and Italy, our Systems Development team collaborates globally to build products that ensure patient health ... Click Here to "Be More" - With the bioMerieux Systems Development Team (https://www.youtube.com/watch?v=hpzozgabt88) Description We develop equipment, tests and… more
- Lilly (Indianapolis, IN)
- …key business partners to deliver standardized data collection methods and innovative validation solutions for use in global clinical trials. Portfolio Delivery + ... design specifications and enable successful implementation + Program and test data collection systems and associated data repository mappings for a trial or set of… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …leadership position. + Competent in complex electronic hardware and software systems design, implementation, validation , and support. + Demonstrated strong ... patients at risk of sudden cardiac death. + HFMS (https://cardiacdiagnostics.zoll.com/products/heart-failure-arrhythmia-management- system /) (Heart Failure Management system ) is a… more
- Insight Global (San Diego, CA)
- …of IT experience working in a pharmaceutical company with exposure to FDA regulations. * Experience supporting validation applications for regulatory purposes ... Leads projects and participates on cross-functional teams to address business systems needs/issues. Plans and develops the analysis of complex business problems… more
- Unither Pharmaceuticals (Rochester, NY)
- …envelope, HVAC & other mechanicals but not limited to filling and packaging systems . Projects include but are not limited to: manufacturing systems , packaging ... systems , new facility construction and upgrades, and other control systems and applications. B. ESSENTIAL DUTIES / RESPONSIBILITIES: Engage in technical… more
- Unither Pharmaceuticals (Rochester, NY)
- …packaging production process. Projects include but are not limited to: manufacturing systems , non-sterile filing systems , packaging systems , process piping, ... facility construction and upgrades, Serialization and other packaging control systems and applications. B.ESSENTIAL DUTIES / RESPONSIBILITIES: Engage in technical… more
- BD (Becton, Dickinson and Company) (Broken Bow, NE)
- …support in the area of debugging of new equipment and may include validation support. + Ensures that all equipment, processes, and facilities meet the requirements ... of designated government regulations such as OSHA, GMP, FDA , EPA, etc. + Troubleshoots problems with the manufacturing...programs as defined for this position in the Quality Systems Manual BD Broken Bow. + Performs other job-related… more
- Medtronic (North Haven, CT)
- …report on quality metrics to company management. Ensure CM compliance with Medtronic Quality Systems , ISO standards, and FDA 21 CFR part 820 regulations. Manage ... standards. Collaborate with CMs to develop and maintain technical quality assurance systems such as MSAs, SPC, Quality Plans, and FMEAs. Support continuous… more
- J&J Family of Companies (Cincinnati, OH)
- …of non-conformances (root cause & corrective action), CAPA, Quality System and process improvement activities **Key Responsibilities:** + Provide leadership ... action risk management, analytics/statistical techniques, requirements management, verification & validation , and design control across the lifecycle of the… more
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