- 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
- Danaher Corporation (Marlborough, MA)
- …and Manufacturing Process Control (MPC) + Effective problem solver with the skills to lead Root Cause investigations / CAPA plans and influence others ... cross-functionally. + Fluent in English and German is a benefit Travel, Motor Vehicle Record & Physical/Environment Requirements: + Ability to travel - 15-20% for supplier audits and GEMBA walks. It would be a plus if you also possess previous experience in: +… 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
- Bristol Myers Squibb (Devens, MA)
- …for handling of records such as change control, product complaints, deviations, investigations , and CAPA management. + Experience working in aseptic/sterile ... for the A2 Shift (6pm to 6am), you will lead a team of 4-8 Specialists. The Shop Floor...management system including but not limited to deviation and CAPA action management, interim production controls, disposition decisions, and… more
- Bristol Myers Squibb (Devens, MA)
- …+ Provide technical support on in CAR-T commercial manufacturing. + Lead projects involving the introduction and qualification of materials, second sourcing ... including change controls, audits, deviations, and QRM programs. + Support investigations and ensure compliance with internal standards and requirements. + Perform… 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
- Sanofi Group (Framingham, MA)
- …cross-functional internal audit activities and conduct walkthrough inspections. + Function as department lead for internal audits + Function as CAPA owner + ... available.** **Main Responsibilities:** + Provide Gemba Support + Function as shift lead including developing junior employees + Perform batch record review +… 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
- Sanofi Group (Northborough, 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