- Cytel (Sacramento, CA)
- …team of consultants and analysts. + Experience interacting with regulatory agencies ( FDA /EMA) and key opinion leaders to enhance development plans. + Collaborative, ... entrepreneurial and self-motivated, with an understanding of the dynamics of high-growth companies; the ability to work effectively in a challenging and sometimes rapidly changing environment. + Minimum of a Masters in Mathematics, Biostatistics, or a related… 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. ... + Collaborate with production and quality teams to identify areas for process improvement and implement corrective actions to prevent defects and non-conformities. + Communicate with the production team to address and resolve quality issues, deviations, or… more
- Grifols Shared Services North America, Inc (San Diego, CA)
- …that ensure control of manufacturing processes in accordance with cGMP. + Knowledge of FDA and EU regulations, ISO requirements. + Skill in the use of computer ... systems for data compilation, managements, and analysis. + Experience with project management (problem solving and resolution) and general business principles. + Excellent written and interpersonal communication skills as well as strategic and conceptual… 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. ... + Collaborate with production and quality teams to identify areas for process improvement and implement corrective actions to prevent defects and non-conformities. + Communicate with the production team to address and resolve quality issues, deviations, or… more
- Fujifilm (Sacramento, CA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... other applicable laws, regulations, and standards. + Comply with and pass all requirements for vendor credentialing as part of gaining access to hospitals and facilities to perform assigned job duties. Key Performance Indicators: + Revenue and sales bookings… more
- Astrix Technology (Gardena, CA)
- …GED. + Minimum 2 years of experience in a regulated manufacturing environment ( FDA , DEA, ISO). + Familiarity with cGMP processes and sampling plan tools preferred. ... + Proficiency in using PPE and Microsoft/ERP systems. INDBH We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected… more
- Astrix Technology (Downey, CA)
- …+ Adhere to GMP procedures and comply with all relevant regulations (eg, FDA ). + Calibrate and maintain laboratory instruments as necessary. + Prepare volumetric ... solutions and perform standardization when required. + Maintain accurate documentation and retain samples as needed. + Follow laboratory safety protocols and properly dispose of hazardous waste. + Keep the workbench area organized and ensure glassware is… more
- Fujifilm (Sacramento, CA)
- …II + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... other applicable laws, regulations, and standards. + Comply with and pass all requirements for vendor credentialing as part of gaining access to hospitals and facilities to perform assigned job duties. **Qualifications:** Professional Experience: + 5-10 years… more
- Schwan's Company (Beaumont, CA)
- …leadership experience + Prior experience in food manufacturing with exposure to USDA/ FDA regulations strongly preferred + Ability to read and interpret documents ... such as safety rules, operating and maintenance instructions, and procedure manuals + Ability to calculate and present financial figures and equipment performance to employees and upper management Compensation and Benefits: The base salary range for this… more
- Terumo Neuro (Aliso Viejo, CA)
- …21 CFR 820 - Device Labeling, 21 CFR 830 - Unique Device Identification, FDA 89-4203, ISO 15223, CDRH Guidance Document, etc.). 6. Advanced experience with MS Visio ... 7. Ability to Create, Update and Maintain MS Project GANTT's 8. Excellent written and verbal communication skills. 9. Proficient with MS Office applications, including Word, Excel, Outlook, and Teams. **Desired Qualifications** 1. Strong knowledge of global… more