- Novo Nordisk Inc. (West Lebanon, IN)
- …your career. Are you ready to realize your potential? The PositionThe Deviation Investigator -Writer is responsible for investigating and writing of deviations ... the technical merit and completeness according to regulatory expectations. The Deviation Investigator -Writer will be responsible for initiating investigations… more
- Curia (Albuquerque, NM)
- Quality Deviation Investigator II in Albuquerque, NM Summary: Curia provides global contract research and manufacturing services to the pharmaceutical and ... biotechnology industries. The Quality Deviation Investigator (QDI) II is responsible for leading investigations to ensure the written report contains… more
- Novo Nordisk (West Lebanon, NH)
- …your career. Are you ready to realize your potential? The Position The Deviation Investigator -Writer is responsible for investigating and writing of deviations ... the technical merit and completeness according to regulatory expectations. The Deviation Investigator -Writer will be responsible for initiating investigations… more
- Lilly (Indianapolis, IN)
- … related Quality System Documents, + Trained as a lead investigator , deviation assessor and approver. Including Private investigations. + Provide advice ... share learning. The Deviation Mentor owns PR&D Deviation procedure and process including the related Quality... Deviation procedure and process including the related Quality System Documents. The deviation mentor is… more
- Lilly (Indianapolis, IN)
- …Overview: The Deviation Mentor is a member of the IPM Quality organization that educates, mentors and guides deviation investigations and analytical ... + Provide advice and guidance to lead investigators in deviation investigation and analytical investigations (assessment, quality ...and develop mitigation plans. + Trained as a lead investigator , deviation assessor and approver. Can act… more
- Actalent (Clayton, NC)
- … Writer Job Description A Global Pharmaceutical Manufacturer is seeking a Quality Investigator for Aseptic Production Investigations. The individual will perform ... investigations specifically pertaining to the Aseptic Core and its processes. Responsibilities include conducting historical searches, reviewing videos, interviewing colleagues, and reviewing supporting documentation (batch records, technical assessments,… more
- Kelly Services (Elwood, KS)
- Kelly Science is seeking a Quality Assurance investigator for a growing company located in Elwood, KS. Summary: As the Quality Assurance Investigator , ... you will be coordinating and conducting activities of the quality assurance department regarding deviation investigation support. Job Duties Include: + Lead or… more
- Fujifilm (Holly Springs, NC)
- …**External US** **About This Role** The Senior Investigator of Deviations Management for Drug Substance Manufacturing ... **What You'll Do** _During project phase_ * Supports the transfer of the deviation management process from the Denmark site. * Authors standard operating procedures… more
- Bristol Myers Squibb (Devens, MA)
- …and other key stakeholders, such as Manufacturing Science and Technology, Quality , Manufacturing Operations, and Validation. **Major Duties & Job Responsibilities:** ... Facility (CTF) at Devens campus. + Act as a deviation author for deviations related to computerized systems (DeltaV,...IT Systems, etc.) at Devens CTF. + Provides IT quality support to Devens CTF Digital Plant team through… more
- MD Anderson Cancer Center (Houston, TX)
- …**KEY FUNCTIONS** Protocol Management: Under supervision of the protocol primary investigator (PI) and the research nurse manager/supervisor assists the ... investigator in the overall conduction of the clinical trials...assisting protocol serious adverse events (SAE) reporting, participating in Quality Assurance (QA) procedure for reporting and monitoring Serious… more
- Ohio University (Athens, OH)
- …to Principal Investigator and/or sponsor + Overseeing and initiating data quality activities including interim monitoring visits and data queries + Management of ... and knowledge in the biomedical research process while ensuring the integrity and quality of clinical research is maintained and conducted at the Heritage College… more
- IQVIA (San Antonio, TX)
- …environment in accordance with the Health and Safety policies. Serves as sub- Investigator for clinical research studies conducted by a supervising principal ... investigator . * Update and maintain skills, training and knowledge...the delivery of care to the volunteer Report any deviation from normal practice to senior staff. * Review… more
- University of Pennsylvania (Philadelphia, PA)
- …Coordinator B/C will work under minimal supervision of the Principal Investigator and Associate Director. Independently manage different phases of clinical trials ... mentor coordinators and research assistants. The role will span industry-sponsored, investigator -initiated, and NIH-funded research across two sites: PCAM and PPMC.… more
- Catalent Pharma Solutions (Bloomington, IN)
- …appropriate corrective and/or preventive actions (CAPA) to prevent reoccurrence. The Investigator assists Operations and Quality Assurance teams to determine ... committed to a Patient First culture through excellence in quality and compliance, and to the safety of every...the initial triage and RPN score of each assigned deviation investigation to ensure it aligns with the company… more
- Charles River Laboratories (Wayne, PA)
- …and timely documentation of all laboratory work. * Independently compose quality documentation including deviation reports and change control documentation ... you can feel passionate about. **Job Summary** Serve as the Principle Investigator Senior Scientist responsible for the development and execution of highly complex… more
- University of Pennsylvania (Philadelphia, PA)
- …and defined regulatory authorities, including submissions, continuing reviews, amendments, deviation and adverse event reporting. Work closely with study sponsors ... meetings. Demonstrate vigilance in patient safety, protocol compliance, and data quality . Adhere to all University of Pennsylvania, FDA and GCP guidelines.… more
- University of Colorado (Aurora, CO)
- …of office coverage, time management of direct reports. + Plans and directs investigator and coordinator meetings including but not limited to team meetings, initial ... evaluations, counseling, and disciplinary actions. + Participates in reviewing and tracking deviation trends leading to review of processes. + Performs quality … more
- Dana-Farber Cancer Institute (Boston, MA)
- …Oncology (GI) department working under the direction of the Principal Investigator (s), Regulatory Operations Manager, and/or directly for the Clinical Trials Office ... interactively with the Office for Human Research Studies (OHRS), Office of Data Quality (ODQ) and the Clinical Trials Offices at the various DF/HCC institutions.… more
- System One (Basking Ridge, NJ)
- …with Academic Research Organizations (AROs), and meetings with CRO and Investigator Meetings. Collect information and coordinate with DS Regulatory Operations to ... document CRO-generated reports, such as site monitoring trip reports and protocol deviation reports and elevate issues to the attention of the supervisor. Compile… more
- University of Miami (Miami, FL)
- …department standard operating procedures, under the supervision of the Principal Investigator (Pl) and supervisor. The Clinical Research Data Specialist is ... to protocol requirements and department policy. + Compiles patient data for Investigator review to determine patient eligibility for protocol enrollment. + Maintains… more
