- Astellas Pharma (Westborough, MA)
- ** Investigations and CAPA Lead ** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are ... programs. AIRM is headquartered in Massachusetts. Astellas is announcing an ** Investigations and CAPA Lead ** opportunity at their **Astellas Institute for… more
- Sanofi Group (Framingham, MA)
- … investigations , independently lead process risk/gap assessments, investigations , change controls & CAPA implementation. Is part of ... product introduction, process transfer & validation, shopfloor support and lead process investigations . The MSAT Drug Substance...MSAT Drug Substance Lead is expected to lead complex and/or multi-step deviations & CAPA … more
- Astellas Pharma (Westborough, MA)
- **Validation Lead , Quality Assurance** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven ... AIRM is headquartered in Massachusetts. Astellas is announcing a **Validation Lead , Quality Assurance** opportunity at their **Astellas Institute for Regenerative… more
- Astellas Pharma (Westborough, MA)
- …+ Quality Records & Investigations : Lead or support quality investigations , risk assessments, and CAPA development. Ensure all quality records are ... will also contribute to inspection readiness, internal audits, deviation and CAPA management, and continuous improvement efforts, ensuring AIRM remains aligned with… more
- Sanofi Group (Framingham, MA)
- …Partners with Quality Assurance to identify events that are deviations. + Supports investigations , reports, and proposes CAPA for minor deviations. + Supports ... Manager and Manufacturing Specialist in the investigation, closure, and CAPA implementation for major and critical manufacturing owned deviations. **Continuous… more
- Nitto Denko Corp. (Milford, MA)
- …their capabilities and development. + Extensive experience in risk management, event investigations , Root Cause Analysis (RCA), and CAPA . + Experience with ... + Review and approve GMP documents, including deviation, change control, CAPA reports, batch records, SOPs, and material specifications, and analytical documents… more
- Cardinal Health (Providence, RI)
- …and suppliers. + May assist in internal and/or external audits + Lead Quality investigations relating to material/vendor investigations **Anticipated ... regulations, standards and operating procedures. + Demonstrates ability to perform investigations / root cause analysis and develop corrective actions. +… more
- Teleflex (Mansfield, MA)
- …products meet customer and quality system requirements. *Support root cause analysis investigations , NC's and CAPA 's, and customer or project related problem ... CT, and Nuevo Laredo, MX facilities. **Principal Responsibilities** *Support or lead sustaining projects and project activities of low complexity with minimal… more
- Sanofi Group (Framingham, MA)
- …robust solutions that have minimal downtime and ensure data integrity + Lead development of automation standards + **Training /Deviations /Compliance/Safety:** + ... Inspection Readiness of assigned areas + Overseeing completion of investigations and deviations + Ensuring all assigned deviations and... and deviations + Ensuring all assigned deviations and CAPA 's are closed in a timely manner + Ensuring… more
- Cardinal Health (Providence, RI)
- …in and hosting internal/external client calibration sessions. + Engage in and lead projects to promote quality enhancements and/or broaden services for the team. ... regulations, standards, and operating procedures. + Demonstrates ability to perform investigations / root cause analysis and develop corrective actions. +… more
- Sanofi Group (Framingham, MA)
- …training + Ensuring Inspection Readiness of assigned areas + Overseeing completion of investigations and deviations + Ensuring all assigned deviations and CAPA 's ... Improvement:** + Working collaboratively with inter-department and cross-functional teams to lead necessary changes in a timely and productive manner + Partnering… more
- Sanofi Group (Framingham, MA)
- …evaluation + ** Lead and** **manage complex contamination control and microbiological investigations ** to identify true root cause and CAPA to prevent ... recurrence. + **Interacting with external bodies & Global Quality to bring knowledge** and awareness of best industry practices (CoP & CoE). + Preparing and participating in **regulatory inspections and audits** , providing expertise on contamination control… more