- CommonSpirit Health (Santa Maria, CA)
- …violations or exceptions, to the study sponsor and IRB as required by GCP, FDA , OHRP and CommonSpirit Health policy. + In conjunction with the PI and other ... facility/clinic staff, may provide direct patient care related to the research protocol. + Conduct informed consent process with research participants; document informed consent discussion and obtain signatures per protocol, federal, state and institutional… more
- Catalent Pharma Solutions (San Diego, CA)
- …SOPs and Catalent systems applicable to work performed. Apply ICH and FDA guidance. Proactively request assistance when needed to prevent deviations and ... investigations + Participate in technical discussions with supervisor and peers. Communicate with clients and intra-company personnel, including delivery of data and notification of OOS/OOT (out of spec/trend) + Stay current with analytical technology industry… more
- Dignity Health (Sacramento, CA)
- …intern has responsibility for assisting with controlled substances management, meeting DEA, FDA , and state regulations, and has access to and manages medication ... storage areas using pharmacy automation. The pharmacy intern fields and triages calls and questions regarding medication distribution, assisting other caregivers within their scope of practice. The intern will also actively participate in clinical and… more
- J&J Family of Companies (Santa Clara, CA)
- …software using C++ and scripting languages such as bash in an FDA regulated environment. + Actively collaborating with cross-functional product partners including ... Product Security, systems, test and service teams. + Adhering to organization and product level quality processes outlined in the Quality Management System. **Qualifications / Requirements:** + BS or equivalent in Computer Science, Computer Engineering, or… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …Lead regulatory effort to comply with new and existing regulations (eg, FDA Medical Device Regulations, EU-MDR) + Support the monitoring, interpreting, and ... implementing of current and new regulatory requirements and international standards for US, EU., and RoW + Assure that QMS requirements are followed and executed consistently from RA perspective + Oversee efforts for Technical File creation and remediation,… more
- Grifols Shared Services North America, Inc (San Diego, CA)
- …+ Maintains accurate and complete training records + Prepares for audits, including ISO, FDA and internal audits + Train Oligo Synthesis Chemist I + Responsible for ... cycle counts to verify inventory accuracy and coordinate with Manufacturing Supervisor/Lead to disposition expired material + Aid metrology liaison to ensure on-time calibration of production equipment + Participate in process improvement projects from… more
- Cordis (Irvine, CA)
- …practices. + Audit Support: Support internal and external audits, including FDA inspections, by providing documentation, data, and expertise related to manufacturing ... quality. + Product Testing: Support and coordinate product testing, equipment qualifications, validation and verification processes to ensure required specifications are met. + Mentor and provide technical guidance to junior engineers, fostering their… more
- Ansible Government Solutions (Fresno, CA)
- …and functionality. + Reassembling and packaging instruments per AAMI, AORN, FDA , OSHA, and manufacturer instructions. + Labeling and documenting sterilized packages ... accurately. + Maintaining records of cleaning, sterilization, and maintenance activities. + Adhering to infection control protocols and wearing appropriate PPE. + Operating within VA standards and national healthcare guidelines. + Participating in training and… more
- Kelly Services (Torrance, CA)
- …contract manufacturing background is highly desirable. + In-depth understanding of FDA regulations, OTC drug monograph compliance, cosmetic labeling, product claims, ... and related documentation. + Demonstrated experience managing complex regulatory workflows, documentation, and cross-functional coordination. + Strong skills in analyzing regulatory requests, resource planning, and process optimization. + Excellent written and… more
- Scripps Health (San Diego, CA)
- …culinary cooking education * Proficiency in Joint Commission, Title XXII, HACCP, FDA Food Code and other applicable regulatory requirements with ability to translate ... into practice. **Job:** **Food / Nutrition* **Organization:** **Scripps La Jolla Hospital* **Title:** *Supervisor, Chef - La Jolla* **Location:** *Central San Diego County-LA JOLLA-SCRIPPS MEMORIAL HOSPITAL LA JOLLA* **Requisition ID:** *252004028* more