- Cytiva (Miami, FL)
- …knowledge of Quality Management System (ISO 9001 or equivalent), cGMP , continuous improvement methodologies, and Manufacturing Process Control (MPC)Effective problem ... solver with the skills to lead Root Cause investigations / CAPA plans and influence others cross-functionally.Fluent in English and German is a benefitTravel, Motor Vehicle Record & Physical/Environment Requirements:Ability to travel - 15-20% for supplier… more
- Cytiva (Miami, FL)
- …knowledge of Quality Management System (ISO 9001 or equivalent), cGMP , continuous improvement methodologies, and Manufacturing Process Control (MPC)Effective problem ... solver with the skills to lead Root Cause investigations / CAPA plans and influence others cross-functionally.. Travel, Motor Vehicle Record & Physical/Environment Requirements:Ability to travel around 10-15% for supplier audits and GEMBA walks.It would be a… more
- Aldevron (Fargo, ND)
- …Experience in technical writing and leading investigations in a cGMP -compliant QC Laboratory setting.Collaboration with External Partners: Experience working with ... external testing laboratories and CMO partners, including support for process and cleaning validation.Lipid Nanoparticles (LNPs): Familiarity with LNPs and related analytical test methods for LNP drug product release.#LI-GC1#LI-OnsiteJoin our winning team… more
- Aldevron (Miami, FL)
- …working in a matrix environment.Experience implementing and executing on cGMP Quality Strategy#LI-GC1At Danaher we bring together science, technology and ... operational capabilities to accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our… more
- Aldevron (Miami, FL)
- …of compliance in the application of current Good Manufacturing Practices ( cGMP ) and Good Documentation Practices (GDP).Strong foundational knowledge in FDA and ... EU regulations specific to labels and labeling such as 21 CFR Part 210, 211, 610, EU Annex 13, EudraLex Vol 4, ICH Q7, ICH Q9, ICH Q10, and international guidelines#LI-GC1#LI-OnsiteJoin our winning team today. Together, we'll accelerate the real-life impact of… more
- Aldevron (Miami, FL)
- …HCCAP, and Quality by Design in compliance with Aldevron and cGMP policies, procedures, rules, and regulations.Job QualificationsBachelor of Science, required.9+ ... years of CDMO and (or) customer-facing experience in a Quality with experience working in a regulated or GMP compliant environment and leading projects or related experience.Exposure to regulatory agency inspections or other types of audits (eg, FDA, notified… more
- Aldevron (Fargo, ND)
- …in:Experience in technical writing and supporting investigations in a cGMP compliant Quality Control Laboratory setting.Experience working with external testing ... laboratories and CMO development and manufacturing partners.Familiarity with lipid nanoparticles (LNPs) and associated analytical test methods.#LI-GC1#LI-OnsiteJoin our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science… more
- Houston Methodist (Houston, TX)
- At Houston Methodist, the Sr. Current Good Manufacturing Practices ( cGMP ) Specialist is responsible for adherence to Standard Operating Procedures (SOPs) and cGMP ... highly regulated radiopharmaceutical drug manufacturing facility in compliance with FDA cGMP guidance. * Capability to lift 50 pounds; **PEOPLE ESSENTIAL FUNCTIONS**… more
- University of Southern California (Los Angeles, CA)
- cGMP Process Development (PD) Specialized Laboratory TechnicianApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA Health-Sciences-Campus/ ... what it is. USC's Keck School of Medicine, current Good Manufacturing Practices ( cGMP ) facility is seeking a dynamic individual to work on the process development… more
- University of Southern California (Los Angeles, CA)
- cGMP Quality Control (QC) SpecialistApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA Health-Sciences-Campus/ cGMP ... of internal/external users in the university's current Good Manufacturing Practices ( cGMP ) facility. The Quality Control (QC) Specialist is responsible for… more
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