- Astrix Technology (New Brunswick, NJ)
- ** QMS Investigator ** Quality Control Middlesex County, NJ, US Pay Rate Low: 35 | Pay Rate High: 37 + Added - 16/10/2024 Apply for Job Our client - a global ... biopharmaceutical company - is seeking a QMS Investigator to join their growing team! **Type:** Contract-to-hire **Pay:** Up to $37/hr **Location** : Middlesex… more
- 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
- Merck (Annapolis, MD)
- …and perform risked-based audits + Activities may include GCP audits of investigator sites, suppliers, third party collaborations and due diligence activities. + In ... oversight of assigned studies. + Assesses compliance of clinical investigator sites, vendors, study activities, clinical study reports and...+ Implement annual audit programs into the Veeva Vault QMS system + Perform routine QC checks and follow… more
- Merck (Rahway, NJ)
- …well as preparation and presentation of the clinical supplies information at Investigator Meetings for assigned protocols. + Support the collection of clinical ... steps in an efficient way, in accordance with established GCS planning SOPs/BPs and QMS Topic 3.4 Change Control Procedures and Work Instructions. + Mentors new team… 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
- 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