- ARTIDIS (Houston, TX)
- …at study sites.Monitoring study progress to assure compliance with protocol requirements, QMS , and regulatory requirements as well as GCP of study sites. + ... and reporting are managed according to protocol, applicable processes of the QMS and regulatory, as well as local requirements. + Conducting remote data… more
- Takeda Pharmaceuticals (Boston, MA)
- …program-specific, risk-based audit and compliance strategies; conduct audits of investigator sites, clinical documentation, vendors, and internal systems to ensure ... timely, and compliant with SOPs and regulatory expectations; perform Principal Investigator (PI) checks prior to study initiation by reviewing audit and… more
- Astrix Technology (Springfield, MO)
- …training to staff on deviation investigations, RCA methodologies, and investigator qualification. + Perform and draft Out-of-Specification (OOS) investigations in ... improvement. + Support continuous improvement initiatives within the Quality Management System ( QMS ). + Ensure all activities comply with applicable GMP, ISO, and… more
- Amgen (Holly Springs, NC)
- …we all use our unique contributions to serve patients. The collaborative investigator we seek has a biologics Drug Substance manufacturing and investigations ... Engineering + Experience leading complex investigations + Experience using Veeva QMS for Deviation investigations and CAPAs + Demonstrated project management ability… more
- NANA Regional Corporation (Madison, WI)
- …required is to perform scientific experiments designed by the Principal Investigator (PI), generate scientific data, and conduct appropriate assay QA/QC analysis ... laboratory notebook, and adhere to guidelines of a Quality Management System ( QMS ). + Collect, curate, and prepare biological and environmental samples for nucleic… more
- Astellas Pharma (Northbrook, IL)
- …in clinical study design, preparation of essential clinical documents (eg, Investigator Brochure, Protocols, Clinical Study Reports), and global health authority ... planning and product label discussions. + Collaborate with teams on inspection readiness, QMS reviews and CAPAs. + Learn the fundamentals of relevant databases (eg,… more