- Cytiva (Pensacola, FL)
- …in QA, Operations, or Quality Engineering preferred. Regulatory and Quality Expertise: Strong knowledge of ISO standards, FDA regulations, cGMPs, CFR ... do: Quality Leadership & Compliance: Serve as the Pensacola site's Quality Management Representative, leading QA/QC functions, ensuring regulatory compliance,… more
- Pall (Miami, FL)
- …Danaher Business System which makes everything possible.Director Global Quality and Regulatory ComplianceJOB SUMMARYInterprets federal/state/international ... or material science fields with 15 years of progressive Regulatory compliance and / or quality assurance...AS9100 / CAA Part 145/CAA Part 21 standards. GMP, FDA knowledge and other ISO standards an advantage.Good understanding… more
- Aldevron (Miami, FL)
- …to maintain labeling integrity.Collaborate with internal stakeholders: Work closely with Regulatory Affairs, Quality Assurance, and Manufacturing teams to ensure ... delivery of solutions that safeguard and improve human health.This position is part of Quality Assurance located in Fargo, ND and will be on site. At Aldevron, we… more
- Beckman Coulter Diagnostics (Miami, FL)
- …the preparation and submission of audit responses and requests for information to FDA , MDSAP Notified Body and other Regulatory Bodies.Utilize Danaher Business ... 9+ years of experience, preferably in areas of medical devices, engineering, or quality assurance.Strong knowledge of Quality , Regulatory compliance, and… more
- Aldevron (Miami, FL)
- …to regulatory agency inspections or other types of audits (eg, FDA , notified bodies, ISO, etc.).Current or past Quality certifications a plus ... and delivery of solutions that safeguard and improve human health.The Sr. Client Quality Manager is responsible for overseeing all duties related to the Quality… more
- Cytiva (Miami, FL)
- …or medical device production.2+ years experience with regulatory standards and quality systems (eg, FDA , ISO 13485, Good Manufacturing Practices - GMP).2+ ... to increase production capacity and improve process performance ensuring compliance with regulatory requirements (eg, FDA , ISO, PSM) and contribute to audits… more
- Aldevron (Miami, FL)
- …audit results.Serve as the site's primary contact with both customers and regulatory agencies regarding quality /compliance issues and Negotiate Quality ... final drug product manufacturing with incoming Quality Management Systems, Quality Assurance and regulatory audits required.Bachelor of Science required;… more
- Aldevron (Fargo, ND)
- …of solutions that safeguard and improve human health.This position is part of the Quality and Regulatory Affairs Department located in Fargo, North Dakota and ... method validation, transfer, and development, demonstrated through publications or previous experience. Regulatory Knowledge: Strong understanding of FDA , EU, and… more
- Aldevron (Fargo, ND)
- …of solutions that safeguard and improve human health.This position is part of the Quality and Regulatory Affairs Department located in Fargo, North Dakota and ... methods utilized at Aldevron are qualified/validated in accordance with current regulatory expectations, in a phase-appropriate manner.This role is onsite in our… more
- Prose (Brooklyn, NY)
- …continuously improve a robust, compliant QMS that aligns with GMP, ISO 22716, and FDA regulatory standards. + Ensure quality policies, SOPs, and ... the internal audits findings to assess compliance with internal and regulatory quality standards. + Manage the lifecycle of CAPAs-from initiation through… more
