- Cytiva (Miami, FL)
- …be a plus if you also possess previous experience in:Understanding of GMP regulationsJoin our winning team today. Together, we'll 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.For more information, visit www.danaher.com. At Danaher, we value… more
- Pall (Miami, FL)
- …of ISO 9001 and AS9100 / CAA Part 145/CAA Part 21 standards. GMP , FDA knowledge and other ISO standards an advantage.Good understanding of applicable regulatory ... requirements covering Food Contact, Product Compliance (Ce Marking, ATEX, ASME etc.), Product Environmental Compliance (ROHS/REACH) and airworthiness (CAA/FAA)The salary range for this role is 155,000 - 180,000. This is the range that we in good faith believe… more
- Cytiva (Miami, FL)
- …in Biochemistry/Chemistry or related fieldFive or more years of experience in GMP , quality, product management or a related fieldUnderstanding of quality and ... regulatory requirements in the Bioprocess industryDriven with experience leading cross-functional activities across global teamsStrong written and verbal communication skills, fluent in EnglishIt would be a plus if you also possess previous… more
- Aldevron (Fargo, ND)
- …implementation of analytical test methods within the QC Laboratory for GMP testing of nucleic acids, proteins, and lipid nanoparticles (LNPs).Lead Deviation ... Investigations: Provide technical expertise as an analytical SME in deviation investigations (eg, Out of Specification (OOS), Quality Events). Assist in identifying root causes and developing Corrective Actions and Preventative Actions (CAPA).Drive Continuous… more
- Aldevron (Miami, FL)
- …related experience in Microbiology laboratory management Experience working within a GMP /regulated environment under a Quality SystemBS in Biology, Chemistry, or ... Molecular Biology or related discipline required, MS preferredDemonstrated leadership ability for direct and indirect reports (coaching, performance management, org structure creation, engagement etc.)It would be a plus if you also possess previous experience… more
- Cytiva (Miami, FL)
- …and quality systems (eg, FDA, ISO 13485, Good Manufacturing Practices - GMP ).2+ years experience with PSM/engineering projects with strong project management skills ... in managing timelines, budgets, and resources for engineering projects.Strong analytical and problem-solving skills with the ability to troubleshoot complex technical issues.Travel, Motor Vehicle Record & Physical/Environment Requirements: if applicable for… more
- Aldevron (Miami, FL)
- …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 bodies, ISO, etc.).Current or past Quality certifications a plus (eg ISO 9001, ASQ, etc.)Strong EQPreferred QualificationsExperience in cell and therapy or biological manufacturing is a plusExperience in… more
- Aldevron (Fargo, ND)
- …the implementation of analytical test methods within the QC Laboratory for GMP testing of nucleic acids, proteins, and lipid nanoparticles (LNPs).Support deviation ... investigations (eg, Out of Specification (OOS), Quality Events) by providing technical assistance and contributing to Root Cause identification and Corrective Actions and Preventative Actions (CAPA).Develop and execute data collection plans, interpret data,… more
- Cytiva (Miami, FL)
- …a regulated environment such as medical devices (ISO 13485), pharmaceuticals ( GMP ), or biotechnology.Proficiency with quality management systems (QMS) and tools like ... Veeva, SAP, Oracle, Magic.Certification in Six Sigma, Lean Manufacturing, or ASQ (CQE, CQA, or equivalent).Cytiva, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a… more
- Beckman Coulter Diagnostics (Miami, FL)
- …of Quality, Regulatory compliance, and operations systems and processes, including GMP and QSR requirements for medical devices. (ISO13485, FDA's QSRs, EU's ... MDD, Canadian Regulations) is required. Proficiency in the Microsoft Office suite of products is required. American Society for Quality certification is preferred.Demonstrates knowledge of domestic and international quality systems and other standards such as… more
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