- Pall (Miami, FL)
- …understanding 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… more
- Cytiva (Miami, FL)
- …device production.2+ years experience with regulatory standards and quality systems (eg, FDA , ISO 13485, Good Manufacturing Practices - GMP ).2+ years experience ... and improve process performance ensuring compliance with regulatory requirements (eg, FDA , ISO, PSM) and contribute to audits and inspections as necessary.Who… more
- Beckman Coulter Diagnostics (Miami, FL)
- …including GMP and QSR requirements for medical devices. (ISO13485, FDA 's QSRs, EU's MDD, Canadian Regulations) is required. Proficiency in the Microsoft ... regulations and standards including compliance with Food & Drug Administration ( FDA ), Medical Device Single Audit Program (MDSAP), ISO13485, European Union Medical… 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 ... through publications or previous experience.Regulatory Knowledge: Strong understanding of FDA , EU, and ICH regulations related to test method validation,… 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… 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 ... test method validation, test method transfer, and method development.Foundational knowledge of FDA , EU, and ICH regulations related to test method validation and… more
- Sanofi Group (Framingham, MA)
- …science, or equivalent + Experience preparing for and direct support of US FDA GMP Pre-Approval Inspections, and follow up activities (eg, inspection response ... **Job Title:** Global Quality Lead, GMP , GDP Audit and Inspection - Pipeline Launch...+ Covers an international scope including major regulators; US FDA (USA), EMA (Europe), ANSM (France), National Medical Products… more
- Actalent (Holly Hill, FL)
- …to employees, identify skill gaps, and recommend training opportunities. 3. Compliance with FDA Regulations, GMP & SOPs * Ensure all activities align with ... Skills Compounding, Blending, documentation review, quality assurance, batch record, gmp , Fda Top Skills Details Compounding,Blending,documentation review,quality… more
- Teleflex (Chelmsford, MA)
- …and ensure compliance with all company policies, rules, procedures, and housekeeping / GMP / FDA standards. **Education / Experience Requirements** * Minimum of ... influence people and teams at all levels. * Knowledge of ISO 13485 / FDA / GMP regulations. * Must be fluent in English. * Demonstrated record of continuous… more
- Herbalife (Winston Salem, NC)
- …for this position. **Experience:** + A minimum of 2 years of experience in FDA or GMP regulated industry **Education:** + High-school diploma (or equivalent) ... + Assist production staff with the correct understanding and implementation of GMP procedures and company policy + Document and investigate (as appropriate) foreign… more
