- Actalent (Framingham, MA)
- Job Title: Quality Deviation Investigator Job Description We are seeking a Quality Deviation Investigator to support the Compliance branch. This ... three deviations simultaneously, including two significant and one non-significant deviation . The successful candidate will be responsible for closing… more
- Dana-Farber Cancer Institute (Brookline, MA)
- The Regulatory Coordinators (RC) works under the direction of the Principal Investigator (s), Clinical Research Manager and / or directly for the Clinical Trials ... Office for Human Research Studies (OHRS), Office of Data Quality (ODQ) and the Clinical Trials Offices at the...other required hard copy submissions to FDA, yearly Principal Investigator Worksheet (PIW) updates for DFCI physicians participating in… more
- Dana-Farber Cancer Institute (Boston, MA)
- …Regulatory Coordinator (RC) works under the direction of the Principal Investigator (s) and Regulatory Operations Manager to complete the regulatory requirements of ... 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
- Bristol Myers Squibb (Devens, MA)
- …Investigations, Cell Therapy** is responsible for leading and supporting deviation investigations within a cGMP-compliant cell therapy manufacturing environment. ... root cause investigations, including impact assessments, and CAPAs as a Lead Investigator + Draft investigation reports and CAPAs, ensuring clarity, accuracy, and… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …This role is central to activating innovative therapies and sustaining high‑ quality research within a multidisciplinary academic environment. **This position's work ... of assigned study monitoring and auditing visits with study coordinator, Investigator , DF/HCC QACT, Industry Sponsors, and third party auditors. **Clinical Trial… more