- BD (Becton, Dickinson and Company) (Brea, CA)
- …and technical QA staff. * Deep knowledge of global medical device regulations ( FDA , EU MDR, etc.). * ASQ certification (Engineer or Manager) preferred. * Six ... Sigma Green Belt or Black Belt certification preferred. * Experience in manufacturing, project management, or engineering is a plus. * International experience and ability to manage global teams and stakeholders. **Knowledge and Skills** + In-depth knowledge… more
- Charles River Laboratories (San Diego, CA)
- …worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits that elevate your ... quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.… more
- Grifols Shared Services North America, Inc (San Diego, CA)
- …Supervises quality control and oversees the fulfillment of applicable building codes, FDA regulations, etc. + Interface directly with customers and suppliers in the ... resolution of specific application problems. This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or… more
- Gilead Sciences, Inc. (Foster City, CA)
- …RMF, protocols, reports) is in full compliance with global regulations and standards ( FDA 21 CFR Part 820/Part 4, ISO 13485). Contribute to the standardization of ... these controlled documents for broader use. **Basic Qualifications** **:** + Bachelor's degree in engineering or a scientific discipline with 10+ years of relevant experience, OR a Master's degree in a relevant field with 8+ years of relevant experience. +… more
- Amgen (Thousand Oaks, CA)
- …Amgen's value proposition. **TEPEZZA(R) (teprotumumab-trbw)** is the first and only FDA -approved therapy for Thyroid Eye Disease (TED), a serious, progressive, and ... potentially vision-threatening autoimmune condition. TEPEZZA is a fully human monoclonal antibody that targets and inhibits the insulin-like growth factor-1 receptor (IGF-1R), a key driver of TED pathophysiology. By blocking IGF-1R signaling, TEPEZZA has been… more
- Keurig Dr Pepper (Los Angeles, CA)
- …safety codes, policies, and procedures of the Company and standards established by OSHA, FDA , and DOT. **Total Rewards:** + $70,000 - $80,000 / year + Actual ... placement within the compensation range may vary depending on experience, skills, and other factors + Benefits, subject to election and eligibility: Medical, Dental, Vision, Disability, Paid Time Off (including paid parental leave, vacation, and sick time),… more
- Danaher Corporation (West Sacramento, CA)
- …preference for 2-5 years in program/project management. + Experience in FDA -regulated/IVDR environments strongly preferred. + PMP or equivalent certification highly ... desirable. + Strong leadership and influence skills in a matrixed organization. + Proven ability to manage PM reports thru multi-disciplinary projects. + Willingness to travel 10-15% (domestic and international). Preferred Attributes: + Demonstrated ability to… more
- Gilead Sciences, Inc. (Foster City, CA)
- …guidance, and health authority expectations in regions including the United States ( FDA ) and the European Union (EMA). + Expert knowledge of relevant parenteral ... drug product pharmacopeial standards (eg, USP, Ph. Eur., JP). + Expert knowledge of aseptic drug product manufacturing and process engineering industrial standards (eg, ISO, PIC/S, ISPE, ISA), best practices, and norms. + Technical leadership experience with… more
- Charles River Laboratories (San Diego, CA)
- …proudly supported the development of 86% of the drugs approved by the FDA in 2021. **Equal Employment Opportunity** Charles River Laboratories is an Equal ... Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status. If you are interested in applying to… more
- Gilead Sciences, Inc. (La Verne, CA)
- …SAP or similar ERP systems for supplier master data + Exposure to FDA inspections, mock audits, and quality systems assessments + Strong interpersonal and ... relationship management skills, with the ability to tailor communication across functions and levels + Experience working cross-functionally with Quality, Tech Ops, Manufacturing, and Supply Chain + Prior background in process development, manufacturing, or… more