- Parexel (Sacramento, CA)
- …applicable. + Ensure document structure, content, and style adheres to FDA /EMA or other appropriate regulatory guidelines, and comply with departmental, corporate ... content review. **Document Project Management** + Act in the capacity of project manager /lead for medical writing projects, which may entail serving as the primary… more
- Astrix Technology (Pomona, CA)
- …personal care products comply with industry regulations and standards, such as FDA guidelines, and work towards continuous improvement in meeting these requirements. ... quality issues, deviations, or non-conformities, and report to the Quality Manager . **Qualifications:** + High school diploma or equivalent. + Proven experience… more
- Gilead Sciences, Inc. (Foster City, CA)
- …ensure utility systems operate within validated parameters and comply with cGMP, FDA regulations, and company safety & quality standards. + Ensure system ownership ... in Microsoft Office Suite. **Preferred Qualifications** + Certified Energy Manager (CEM). + Experience with commissioning, qualification, and validation of… more
- Stryker (San Diego, CA)
- …and operation of trade shows, conventions, and/or clinical meetings. + Keeps regional manager informed of territory progress on a regular basis. + Solves product ... Must adhere rigidly to all GMP policies and procedures as stipulated by the FDA . QUALIFICATIONS: + 0-2 years in an outside sales position (medical related fields is… more
- Roche (Santa Clara, CA)
- …+ You are able to identify improvements and implement through collaboration with your manager . + You act as a coach for colleagues with less experience and help ... and principles; familiarity with the ISO 27001 family of standards and FDA cybersecurity guidance documents + Exposure to or familiarity with software development… more
- Parexel (Sacramento, CA)
- …Management and Monitoring (DSMM) + Partners with SCP and Country Study Operations Manager (SOM) + When required Partners with other Study Team members (eg Clinician, ... + Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration ( FDA ) and local country regulations + Must be fluent in English and in… more
- GRAIL (Menlo Park, CA)
- …with cross-functional teams to deliver scalable data solutions aligned with FDA and global health authority requirements. Our ideal candidate brings experience ... total work week be on-site. Your specific schedule, determined in collaboration with your manager , will align with team and business needs and could exceed the 40%… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and continuous improvement. + Ensure changes to commercial products comply with FDA QSR/QMSR, ISO 13485, and other applicable standards. + Maintain compliance with ... certifications (Certified Quality Auditor, Certified Quality Engineer, Certified Quality Manager ) or equivalent. + Familiarity with emerging regulatory requirements… more
- Mentor Technical Group (Millbrae, CA)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... and cost saving initiatives). + This role requires a skilled senior manager with pharma engineering experience, compliance and safety focused. + Strong operational… more
- Moonlight Companies (Reedley, CA)
- Job Summary Assist the Food Safety Manager to coordinate, develop, implement the food safety/security regulations, policies and procedures for packing, cooling and ... years of food safety experience, knowledge and experience with HACCP, USDA, or FDA preferred. + Previous experience with SQF, GFSI, Primus, BRC, GMP's, GAP'S and/or… more