- Neotech (Chatsworth, CA)
- …and equipment databases to ensure compliance with customer requirements, FDA regulations & ISO specifications. + Support Corrective Action/Preventative Action ... initiatives relating to assignment and verification & follow up from a 7-step problem solving methodology. + Support Lean and Shingo initiatives by team participation and action item support, with required metric development and maintenance. + Manage & support… more
- Takeda Pharmaceuticals (Los Angeles, CA)
- …+ Experience in a manufacturing environment (5+ years preferred) + FDA /cGMP experience preferred + Ability to foster a collaborative, team-oriented environment ... + Strong problem-solving, organizational, and administrative skills + Ability to manage priorities and balance responsibilities of self and direct reports + Proficiency in analyzing and interpreting scientific and statistical data + Knowledge of cGMPs and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …drug product development, commercial technology transfer to manufacturing, CMC related FDA and international regulations + Previous success working effectively in a ... multidisciplinary, highly matrixed environment + Demonstrated ability to build a team and develop a high performing organization + Excellent decision-making, written and verbal communication skills + Proven ability to lead high performing teams + Exceptional… more
- Abbott (Alameda, CA)
- …levels of the organization. + Ensure all automation processes comply with FDA , ISO 13485, and other relevant regulatory standards. + Maintain detailed documentation ... for audits and CAPA (Corrective and Preventive Action) processes. + Maintain robust cybersecurity, privacy, and security protocols. + Maintain system protocols by implementation policies and procedures in accordance with Quality Management System (QMS)… more
- J&J Family of Companies (Irvine, CA)
- …performing statistical analyses in a regulated environment, preferably medically related including FDA , GCP or other relevant area. Johnson & Johnson is an Equal ... Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics… more
- System One (Irvine, CA)
- …years of manufacturing experience with 10+ years in a management role + FDA GMP regulation experience + Requires breadth of organizational, professional field and ... industry knowledge #M3 #LI-MD1 Ref: #558-Scientific System One, and its subsidiaries including Joule, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help… more
- Gilead Sciences, Inc. (Foster City, CA)
- …process scale-up to pilot and manufacturing scale equipment. + Understanding of FDA , EMA, and ICH regulatory guidelines related to cGMP. + Excellent communication, ... technical writing, and presentation skills and aptitude for creative problem solving. + Demonstrated ability to collaborate and influence cross-functionally. + Experience in statistics, design-of-experiments, and data analysis (eg JMP, Spotfire). +… more
- J&J Family of Companies (Santa Clara, CA)
- …and improve usability. + Proven knowledge of the IEC 62366 standard and the FDA guidance on human factors engineering. + Solid understanding of ISO 14971 and IEC ... 62304. + Medical Device product development or experience working in a highly regulated industry. + Fluency in English, both written and verbal. + Willingness and ability to travel up to 20%, both domestically and internationally. **Preferred:** + Clinical… more
- ThermoFisher Scientific (San Francisco, CA)
- …commercial drug substance manufacturing, or commercial drug product manufacturing in an FDA regulated environment is required. + 5 years consistent track record of ... leading teams. + Experience with engaging externally facing customers within a contract development and manufacturing organization (CDMO) highly preferred. + Commercial biologics manufacturing experience is required. **Knowledge, Skills, Abilities** + Ability… more
- UCLA Health (Los Angeles, CA)
- …and all required applications and forms related to internal UCLA requirements, FDA requirements, sponsor requirements, etc. You will also work with study monitors ... to process, review and collect the appropriate regulatory documents in a timely manner and in compliance with federal, state, and university mandated laws, regulations and policies. Pay Range: $31.51 - $62.64 hourlyQualifications Required: + 1+ years of… more