- Amgen (Thousand Oaks, CA)
- …site meets the quality requirements of its customers and applicable regulations ( FDA , EU & global standards). + Assist in the development of any existing ... a matrix team environment, collaborating with Process Development, Project Management, Manufacturing, Regulatory , Quality and Compliance. + Ability to learn and… more
- Pfizer (South San Francisco, CA)
- …of related disciplines, eg, Clinical Operations, Safety, Biostatistics, Regulatory , Study Management, Pre-Clinical, Pharmacology, Quality Assurance. ... of clinical studies and delivering on innovative clinical study designs, high quality trial execution, safety assessment and interpretation of clinical study results… more
- Bausch Health (Los Angeles, CA)
- …and strong work ethic to include; + Maintaining compliance with all applicable quality and regulatory guidelines including FDA and corporate guidelines. ... consumables or medical products to plastic surgeons or dermatologists in a FDA regulated, highly controlled environment. + Ideal candidates will also have knowledge… more
- J&J Family of Companies (Santa Clara, CA)
- …in formal security audits (ie HITRUST, SOC2, FedRAMP) + Familiarity with FDA and/or other global regulatory cybersecurity guidance requirements and submission ... recommendations of security design solutions, ensure the team completes Quality documentation, threat modelling, penetration testing, software architecture review… more
- Owens & Minor (Fairfield, CA)
- …+ Tuition reimbursement **ABOUT THE COMPANY** _Apria Healthcare's mission is to improve the quality of life for our patients at home. We are looking for empathetic, ... medical supplies onto delivery vehicle. + Complies with all applicable regulatory requirements including providing documents needed for the driver qualification file… more
- Philips (Ontario, CA)
- …areas. The role is site based in Ontario, CA - an air-conditioned FDA regulated manufacturing environment for Medical Devices and Pharmaceutical drugs (ISO 13485). ... **Your role:** + Effectively work in a high volume, fast paced FDA regulated manufacturing environment providing safety orientation and trainings to employees,… more
- BeOne Medicines (Emeryville, CA)
- …with QMS implementation and process ownership. + Deep understanding of quality management principles, regulatory frameworks, and industry standards (eg, ... and ensuring the effectiveness, compliance, and continuous improvement of the Quality Management System processes. This role involves designing, implementing, and… more
- Barry Callebaut (American Canyon, CA)
- …protocols. * Foster a culture of continuous improvement, accountability, and teamwork. Regulatory Compliance * Ensure compliance with OSHA, FDA , USDA, EPA, ... transform the cocoa and chocolate industry. As the world's leading manufacturer of high- quality chocolate and cocoa products, our actions truly shape the future of… more
- Ascendis Pharma (Palo Alto, CA)
- …PV Compliance team will provide appropriate representation during PV related regulatory inspections or internal quality assurance/corporate compliance audits. . ... all applicable laws and regulations and as appropriate, local and foreign regulatory reporting requirements and for signal detection, evaluation and risk management.… more
- Ascendis Pharma (Palo Alto, CA)
- …(Argus preferred) + Experience with MedDRA coding and global safety reporting regulatory requirements. + Working knowledge of FDA safety regulations, ICH ... the oversight of the PV Vendor processing ICSRs for Ascendis Products. + Performs Quality Checks of processed ICSRs and provides feedback to PV Vendor as applicable.… more