- System One (Monmouth Junction, NJ)
- …in a cGMP-regulated environment. This role involves operating packaging equipment, ensuring compliance with batch records and FDA guidelines, and maintaining ... records and other required documentation. + Follow SOPs, cGMPs, FDA standards, and safety procedures at all times. +...all times. + Collaborate with production staff to meet quality and production goals. + Perform general housekeeping and… more
- University of Miami (Miami, FL)
- …such as the Institutional Review Board (IRB) and the Food and Drug Administration ( FDA ). This role is essential for ensuring compliance and supporting the ... team with data collection, data entry and completing standard operating procedures for quality assurance reviews of data as needed. + Assists PIs and study team… more
- Stanford Health Care (Redwood City, CA)
- …in ongoing education and training, communication and adherence to safety and quality programs, sustaining compliance with National Patient Safety Goals, and ... Ordering, Furnishing or Prescribing of Drugs; Formulary Protocol] Medications that are not FDA -approved or are used for a non- FDA - approved indication (off-label… more
- GRAIL (Menlo Park, CA)
- …with internal teams to implement appropriate changes. + Support internal and external quality audits. + Ensure compliance with all regulations and laws ... and other relevant documentation. The role collaborates cross-functionally with Quality , Lab Operations, and other stakeholders to support regulatory strategy… more
- Mixlab (Los Angeles, CA)
- …to oversee pharmacy operations across multiple sites and ensure continued excellence in quality , compliance , and service. This role will serve as the PIC ... (API) components when they are not available via an FDA -registered facility. Monitoring and observing compounding activities and taking...in preparation of the Annual PI Report with the Compliance team + Report ADRS, internal quality … more
- Bristol Myers Squibb (Devens, MA)
- …before our stakeholders, and management. + Understanding of SOPs, cGMPs and compliance requirements and regulatory guidelines ( FDA , EU) and the technical ... function, Manufacturing Systems, Information Technology, Manufacturing, Manufacturing Engineering and Quality Effectively manage workload to address priorities, meet schedules,… more
- Virginia Mason Franciscan Health (Seattle, WA)
- …protocols and safety standards. Keep precise and thorough patient records, guaranteeing compliance with MQSA, ACR, and FDA regulations. Operate and maintain ... under direct supervision to harness your specialized skills to produce high- quality mammographic images for both screening and diagnostic purposes tailored to… more
- Astellas Pharma (Sanford, NC)
- …proactively assure compliance to all applicable internal, domestic, and international quality regulations. This role is the first point of contact for ensuring ... and alignment with departmental/site/global goals. + Establish and foster a cGMP quality culture that prepares the site for regulatory pre-approval inspections and… more
- J&J Family of Companies (Santa Clara, CA)
- …products being developed + Support company goals and objectives, policies and procedures, Quality Systems, and FDA regulations + Other duties as assigned ... processes by working closely with research/development, operations, regulatory, and quality teams. **Essential Job Functions** + Develop product(s) for manufacturing… more
- J&J Family of Companies (Santa Clara, CA)
- …and manufacturing environments (ISO, FDA , cGMP). + Knowledge of and compliance with applicable Quality System requirements (eg, traceability QSRs, ISO and ... or tooling as appropriate, troubleshooting and implementing changes to improve manufacturing quality and product performance. The Senior Engineer will assist in the… more