- Praxair, Inc - a Linde Company (Fresno, CA)
- …Specialist will work extensively with Regional & Corporate Quality personnel to ensure Manufacturing and Warehousing locations meet or exceed FDA and corporate ... assigned locations in training Managers, supervisors and personnel on Company and FDA GMP procedures + Audit/Assess assigned LG&E manufacturing and warehousing… more
- Globus Medical, Inc. (Audubon, PA)
- …submissions, and approval for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This position entails development of ... FDA submissions, requires working knowledge of products under review...trials + Helps to prepare PMA packages, including non-clinical, manufacturing , and clinical sections + Works with personnel in… more
- Cambrex High Point (Longmont, CO)
- …Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical ... generic markets for API and dosage form development and manufacturing . Your Work Matters. At Cambrex, we strive to...accuracy and compliance with other regulatory guidelines. * Under manager supervision, able to comply with GMP, SOPs and… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …FDA and notified body site inspections. + Interface with the FDA on Post-Market Activities: site inspections, manufacturing complaints, additional information ... the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the… more
- Mallinckrodt Pharmaceuticals (St. Louis, MO)
- …the Safety, Quality, and cost Effectiveness of the maintenance and manufacturing operations in his/her area. The Maintenance/Operations Shift Supervisor will also ... + Ensure compliance with government agencies for current Good Manufacturing Practices (cGMP) as applicable for production (.i.e. OSHA,... Practices (cGMP) as applicable for production (.i.e. OSHA, FDA , DEA, DOT, EPA, and any others that may… more
- DuPont (Hemlock, MI)
- …management system in accordance with relevant standards and cGMP (Good Manufacturing Practices) and drives continuous improvement to meet the performance objectives ... trends or isolated events. As this is supporting an FDA regulated business, this role also assures QMS, and...and process streams meet regulatory requirements including cGMP (Good Manufacturing Practices). The Quality Engineer II will report to… more
- Access Dubuque (Dubuque, IA)
- …Responsible for product processing, packaging, and storage in compliance with FDA , USDA, and Simmons rules and regulations. ESSENTIAL POSITION RESPONSIBILITIES Leads ... performance which meets or exceeds all line, department, facility, company, and USDA/ FDA guidelines or grading process for a total quality program and customer… more
- Mallinckrodt Pharmaceuticals (Webster Groves, MO)
- …The position provides Quality oversight and support for Webster Groves manufacturing facility. The position will provide leadership and support for continued ... is to ensure compliance with cGMP, regulatory and internal requirements regarding the manufacturing , testing and distributing of products as well as projects such as… more
- Merck (Durham, NC)
- …for highly motivated individuals with expertise working in aseptic production and manufacturing operations. The Lead Technician is a manager developmental role ... **Job Description** Our Manufacturing Operations teams are the people that make...+ Executes room incursion initiation and approvals + Assists Manager in leading a team-based culture through continuous improvement… more
- Access Dubuque (Dubuque, IA)
- …Responsible for product processing, packaging, and storage in compliance with FDA , USDA, and Simmons rules and regulations. **ESSENTIAL POSITION RESPONSIBILITIES** ... performance which meets or exceeds all line, department, facility, company, and USDA/ FDA guidelines or grading process for a total quality program and customer… more