- 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
- 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
- Integra LifeSciences (Braintree, MA)
- …standards, and optimizing operational efficiency. This role involves conducting equipment investigations and Corrective and Preventive Actions ( CAPA ), overseeing ... and preparing for FDA audits. **JOB RESPONSIBILITIES** **Equipment Investigation and CAPA :** + Conduct thorough investigations into equipment failures and… 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
- 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
- AMETEK.Inc (Peabody, MA)
- …to foster a collaborative, high-performance work environment. + Root Cause Analysis: Lead investigations into product defects, process deviations, and production ... & Manufacturing Engineering Manager at TMC Vibration Control, you will lead the optimization of our quality assurance and manufacturing engineering operations,… 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
- 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)
- …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
- 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
- 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)
- …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