- 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
- Philips (Cambridge, MA)
- …processes. Leading and mentoring a team of quality professionals, providing guidance on CAPA investigations and documentation. **You're the right fit if:** + You ... The Senior Quality Manager- CAPA will play a critical role within Philips'...management skills (MS Project preferred) with the ability to lead multiple initiatives simultaneously. + You have a minimum… 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
- 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
- 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
- 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 A1 Shift (6am to 6pm), 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
- 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
- Insight Global (Chelmsford, MA)
- …the site. Partner with operations, engineering, and leadership to support CAPA investigations , nonconformance reduction, and line-down resolution. Mentor and ... understanding of quality tools and methodologies (eg, 5 Whys, Fishbone, CAPA ). Proven ability to lead teams through change and drive performance in a regulated… more
- Integra LifeSciences (Boston, MA)
- …quality audits, eQMS, risk assessment, process qualification, process controls, root cause investigations , CAPA , and continuous improvement + Provide support to ... Forums + Collect and analyze performance data against defined parameters. + Lead the identification and resolution of quality issues and complaints, including… 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)
- …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
- 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
- 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