- Hologic (San Diego, CA)
- …product complaints in compliance with Hologic SOPs and applicable regulatory requirements ( FDA , ISO, EU MDR). + Conduct initial assessments and work with ... Regulatory Reporting + Support preparation and submission of regulatory reports (eg, FDA MDR, EU Vigilance, FSCA/FSN) according to global regulatory requirements. +… more
- J&J Family of Companies (Santa Clara, CA)
- …teams and business functions, manage audit/inspection outcomes with Notified Bodies and FDA , lead and drive effective oversight of CAPA Program and drive ... and facilitating successful audits and inspections with regulatory bodies including FDA and various Foreign Government Health Authorities and Notified Bodies. +… more
- Charles River Laboratories (Northridge, CA)
- …adhere to quality standards and relevant regulatory requirements (eg, GxP, FDA , ISO) **Job Qualifications** + Bachelor's degree in life sciences, bioengineering, ... drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. At Cell Solutions,...the development of 100% of the current commercially available FDA -approved immunocellular therapies. Our mission is to provide a… more
- ABM Industries (Carlsbad, CA)
- …to the development, implementation and effectiveness of Quality Management System per ISO, FDA , and other regulatory agencies. + Understands and is aware of the ... Remain knowledgeable of current federal and international regulations, including FDA 21CFR part 820, FDA 21CFR part 11, and ISO 13485. Maintain working knowledge… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …testing of samples. + Strict adherence to procedures and practices according to FDA regulations. + Strong emphasis on documentation according to FDA regulations. ... Bachelor's degree preferred. + Related experience in a pharmaceutical, GMP, or FDA regulated environment is preferred. + Requires a basic understanding of the… more
- Biomat USA, Inc. (Upland, CA)
- …state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA), ... state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA),… more
- Envista Holdings Corporation (Thousand Oaks, CA)
- …process discipline required in a Class 1 and Class II FDA -regulated manufacturing environment. Their organizational, communication, and leadership skills are second ... of continuous improvement. + Work within the company's corporate quality system and ISO/ FDA regulations to remain compliant. + Develop and manage the plan for… more
- Astrix Technology (Rancho Dominguez, CA)
- …and discrepancies as neede + Ensure all documentation complies with applicable FDA , SQF, and other regulatory standards + Assist with identifying and resolving ... food manufacturing environment + Familiarity with food safety programs and policies ( FDA , USDA, AIB, HACCP, GMP, Allergen Programs) + Knowledge of labeling… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …a large-scale and rapidly evolving business. + Provide operations and quality leadership during FDA and notified body site inspections. + Interface with the FDA ... MDSAP, CMDR, ISO 13485, J-PAL) requirements, Quality Assurance/Control, Statistical analysis, and FDA QSR's (21 CFR Part 820) **Required Knowledge and Skills** +… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …+ Minimum of 2 years of related experience in a pharmaceutical, GMP, or FDA regulated environment is required. + Equivalency: In lieu of an Associate's degree, ... minimum of 4 years of related experience in a pharmaceutical, GMP, or FDA regulated environment. + Requires an in depth understanding of pharmaceutical manufacturing… more