- Cytiva (Miami, FL)
- …about the Danaher Business System, which makes everything possible.As the Senior Manager , Site Quality you will collaborate closely with cross functional leadership ... Operations within Life Sciences, Biotechnology, Medical Device, Biopharma, or other FDA or EPA-regulated manufacturing environments.Possess a minimum of 4 years of… more
- Aldevron (Miami, FL)
- …of solutions that safeguard and improve human health.The Sr. Client Quality Manager is responsible for overseeing all duties related to the Quality Manufacture, ... 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… more
- Beckman Coulter Diagnostics (Miami, FL)
- …activities. In addition, the CAPA GPO will also take on the role of CAPA Manager of the Global CAPA Review Board (CRB). This position is part of the Global ... of the Global Process Owner (GPO) Team and report to the Senior Manager of Global Quality responsible for overseeing various Global Quality Management System… more
- Cytiva (Miami, FL)
- …understanding of healthcare manufacturing and PSM standards.This position reports to the PSM Manager and is part of the Pensacola Operations and Safety teams located ... and improve process performance ensuring compliance with regulatory requirements (eg, FDA , ISO, PSM) and contribute to audits and inspections as necessary.Who… more
- Aldevron (Fargo, ND)
- …a part of the Analytical Method Validation Team and report to the Sr. Manager of Analytical Method Validation and will be responsible for representing the Analytical ... through publications or previous experience.Regulatory Knowledge: Strong understanding of FDA , EU, and ICH regulations related to test method validation,… more
- Beckman Coulter Diagnostics (Miami, FL)
- …the Quality Assurance - Validation team and report to the Quality Assurance Manager responsible for Validation. If you thrive in a multifunctional, supporting role ... test method, equipment, process, and/or design testing methodologies.Knowledge of FDA regulations, ISO standards, and GxP guidelines.Experience with Computer System… more
- Aldevron (Miami, FL)
- …of the Operational Quality Assurance team and report to the Sr. Manager , Operational QA, responsible for Developing and implementing labeling processes and ... Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).Strong foundational knowledge in FDA and EU regulations specific to labels and labeling such as… more
- Aldevron (Fargo, ND)
- …a part of the Analytical Method Validation Team and report to the Sr. Manager of Analytical Method Validation. You will assist in representing the Analytical Method ... test method validation, test method transfer, and method development.Foundational knowledge of FDA , EU, and ICH regulations related to test method validation and… more
- Cytiva (Duncan, SC)
- …Control and Sterility Assurance management.This position reports to the Sr. QA Manager Contamination Control and Sterility Assurance US Region and is part of ... and industry standards for sterility assurance and contamination control (eg, FDA , EMA, ISO).Proven experience in developing and implementing sterility assurance… more
- Cambrex High Point (Longmont, CO)
- …that all activities are in compliance with company SOPs, cGMP/cGLP standards and FDA /EU regulations. The Manager of Quality Assurance leads and mentors the ... where You Matter by applying today! Job Overview The Manager of Quality Assurance is responsible for the daily...and maintenance of procedures and policies to comply with FDA , EU, and ICH requirements applicable to site's needs.… more
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