- Fresenius Medical Center (Waltham, MA)
- …Quality Business process/function(s). + Responsible for assigned CAPAs and will act as CAPA lead to CAPA Owner/Team providing project direction throughout ... **PURPOSE AND SCOPE:** The Senior Engineer, CAPA is responsible for coaching CAPA ...ensure CAPAs (corrective and preventive action) and Non-Conformance (NC) investigations are executed in compliance with company procedures and… more
- Takeda Pharmaceuticals (Boston, MA)
- …Program Quality, Deviation Management and Serious Breach review board meetings. + Lead complex quality investigations impacting the clinical trial delivery ... Description** **About the role:** Associate Director, Clinical Program Quality Investigations is responsible for ensuring the compliance of deviation management… 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
- Takeda Pharmaceuticals (Boston, MA)
- …proactively assess the needs for functional processes and system enhancements + Lead the development of internal functional processes and training and ensure ... CPMQ teams to foster a culture of learning and continuous improvement + Lead CPMQ continuous improvement initiatives to enable optimization of clinical and safety… more
- Sanofi Group (Cambridge, MA)
- …Provide Quality impact assessment for product changes + Provide quality input into CAPA and nonconforming product investigations + Support root cause ... **Job Title:** Digital Device Quality Engineering Lead **Location** : Cambridge, MA **About the Job**...Global Digital Team as a Digital Device Quality Engineering Lead . You will be responsible for the quality assurance… more
- Integra LifeSciences (Boston, MA)
- …as inspection reports, test records, and Device History Records + Conducts CAPA investigations , proposes corrective and preventative actions, and conducts ... to advance patient outcomes and set new standards of care. The Lead Quality Assurance Coordinator (formerly, Quality Assurance Specialist II) supports QA oversight… 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
- Chewy (Boston, MA)
- …(KPIs) to monitor regulatory adherence and provide executive reporting. **_Compliance Investigations & Risk Management_** Lead high-impact compliance ... action ( CAPA ) plans are effectively executed and scalable. + Lead internal compliance assessments and regulatory verification processes to ensure and maintain… more
- Medtronic (Danvers, MA)
- …quality for Class II/III medical devices in a regulated manufacturing environment + Lead and support nonconformance investigations , CAPA (Corrective and ... and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected,… 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 (Boston, MA)
- …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
- 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
- Takeda Pharmaceuticals (Boston, MA)
- …Operating Procedures (SOPs), Analytical Risk Assessments, Product Specifications, Laboratory Investigations , Change Controls, Deviations, CAPA , Protocols and ... and European Medicines Agency (EMA) regulations; act as project lead on development of an in-house specialized immunoassay for...Cell Protein (HCP); act as primary contact and project lead for development of a novel HCP method: Liquid… more
- Curia (Burlington, MA)
- …maintenance + Maintaining supplies and inventory + General laboratory housekeeping + Lead microbiology investigations , propose appropriate CAPA (s) and assure ... verbal and written communication skills, including the ability to proficiently lead business meetings and work related social and business development situations… 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 (Boston, MA)
- …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)
- …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