- 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
- J&J Family of Companies (Horsham, PA)
- …CAPA Investigation Quality System area. + Demonstrated experience as an investigator of Non-Conformance/CAPA process. + Excellent communication and writing skills ... Escalation, Problem Solving, Quality Control (QC), Quality Management Systems ( QMS ), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)… 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
- Teleflex (Olive Branch, MS)
- …analysis of trend data. * Customer Complaint Investigations - Primary investigator and facilitator for Conductor complaint investigation, confirmation and corrective ... reviews. Compiles and writes training material and conducts training sessions on QMS & Quality assurance activities. * Manage and lead implementation of continuous… more
- Lilly (Indianapolis, IN)
- …equipment failures, troubleshooting, demonstrating RCA (Root Cause Analysis) lead investigator proficiency and guiding operations personnel in the resolution of ... (Computerized Maintenance Management Systems), U/BMS (Utility/Building Management Systems) and QMS (Quality Management Systems). + Demonstrated office software skills… 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