- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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)
- …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