- Philips (Cambridge, MA)
- …**Your role:** + Facilitate product and process Corrective and Preventive Action ( CAPA ) investigations from issue identification through implementation of ... Senior CAPA Engineer is responsible for driving CAPA activities from issue identification to closure,...per project timelines. + Represent CAPAs during audits and CAPA Review Board meetings. Lead and mentor… more
- ThermoFisher Scientific (Greenville, NC)
- …units within the organization . + This candidate is responsible for driving investigations , CAPA plans, audits, inspection findings, etc. + Drives and owns ... (Mon-Fri) **Environmental Conditions** Office **Job Description** **Clinical Operations Excellence Lead (COEL), Project Management - FSP Dedicated** At Thermo Fisher… more
- L3Harris (Mason, OH)
- …quality control and Green Belt techniques. + Lead teams and perform investigations to drive CAPA for nonconformance, as well as actively participate in ... Job Title: Lead Supplier Quality Engineer Job Code : 19080...supports the day-to-day operations and is responsible for tactical issue resolution for supply chain related quality issues; both… more
- IQVIA (Durham, NC)
- … and CAPA processes at IQVIA. This will include Quality Issue investigations and Customer Audit/ Regulatory Inspection Responses, Corrective and Preventative ... review, approval and closure. **Your responsibilities will include:** + To lead global investigations and support teams with CAPA preparation in compliance… more
- Lilly (Indianapolis, IN)
- …leads the site metrics related to deviation system. He/she can also lead complex investigations . They participate in regulatory inspections and collaborate ... investigation matters. Responsibilities: + Provide advice and guidance to lead investigators in deviation investigation and analytical investigations … more
- Reckitt (Wanamingo, MN)
- …ensure compliance to QMS. . Perform or review manufacturing non-conformances reports, CAPA , failure investigations and audit findings to report manufacturing ... Compliance Assurance Lead /Associate (Days; 6:00 AM to 6:00 PM) City:...corrective action. . Prepare and analyze metrics for EM, CAPA , suppliers' performance to drive continuous improvement . Interface… more
- The Clorox Company (Forest Park, GA)
- …Processes to mandate and drive compliance. This role includes responsibility in Investigations (RCA & CAPA ) and report writing skills, data analysis ... Clorox:** The Clorox- Atlanta West facility is seeking a qualified individual to lead in the technical areas of our Quality department, the individual will prepare… more
- Insight Global (Murrysville, PA)
- Job Description Facilitate product and process Corrective and Preventive Action ( CAPA ) investigations from issue identification through implementation of ... solution and effectiveness monitoring. Represent CAPAs during audits and CAPA Review Board meetings. Lead and mentor...Can you describe a time when you identified an issue in the production process that could have caused… more
- Novo Nordisk (Bloomington, IN)
- …and provide insight into potential issues and suggest solutions + Ability to lead technical calls and discussions regarding investigations , audits, or other ... SME's to quickly identify the potential scope of an issue and as required escalate to Leadership to ensure...where possible and is linked to clear and actionable CAPA + Provides a summary presentation of the draft… more
- WuXi AppTec (Philadelphia, PA)
- …upon client contractso Provides leadership to a team that leads complex technical investigations , CAPA /action plans and change controlso Provides support to late ... offerings. + Technical support and troubleshooting of routine manufacturing, technical investigations , CAPA /Action Plan, and Change Control leadership. + Process… more
- Boehringer Ingelheim (Fremont, CA)
- …proper change control, corrective action and preventive action plans ( CAPA )/Deviation management, impact assessments for changes to equipment and processes, ... risk management, and ensuring documentation and investigations meet all requirements. With autonomy and authority, makes difficult decisions with little time for… more
- IQVIA (Greensboro, NC)
- …approve investigations , Root Cause Analysis (RCA), Corrective Action Prevention ( CAPA ) and Effectiveness Check (EC) plans and track till closures for quality ... driving compliance in a highly regulated industry through audits, functional support, issue & CAPA management, regulatory consultancy, management of data… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- …critical decisions pertaining to quality system objectives. + Performs deviation investigations and coordinates CAPA implementation as needed for high-risk ... management and facilitation of the Approved Supplier List (ASL), deviation investigations , CAPAs, supplier audit closures and evidence follow up, support of… more
- Hovione (East Windsor, NJ)
- …facilities that can meet user and technical requirements. - Perform deviation investigations and CAPA implementation as per applicable procedures in place ... technical solutions are dully incorporated - Handling GMP/cGMP perspectives like CAPA , protocols and deviations - Execute the construction, assembly, commissioning… more
- Kelly Services (Redmond, WA)
- …needing to bring in cross functional teams, driving with urgency to resolve the issue . + Contain nonconforming product and work with the Operations team when a line ... internal and supplier-driven Non-Conformances (NC) and Corrective Action Preventative Action records ( CAPA ), managing the timely processing and closure of NC and … more
- L3Harris (Mason, OH)
- …quality control and Green Belt techniques. + Lead teams and perform investigations to drive CAPA for nonconformance, as well as actively participate in ... day-to-day operations and is responsible for tactical and/or technical issue resolution for supply chain related quality issues; both...such as 8D, Six Sigma, Value Stream Mapping, and CAPA . + Experience in working and communicating effectively in… more
- Hovione (East Windsor, NJ)
- …appropriate colleagues, complete relevant section/s of the event or deviation - Lead and participate in root-cause investigations , guiding colleagues (as ... in accordance with appropriate standards and propose revisions as required - Issue and follow-up change controls - Assure good functioning equipment, planning and… more
- Endo International (Rochester, MI)
- …commercial products. This position also monitors, tracks, and trends Non-Conformances, CAPA , complaints and other Quality Systems, assesses the risk level associated ... with Non-Conformances and escalates the issue to management. Opportunities for continuous improvement of advanced...with contractors or other staff to ensure resolution of investigations , deviations and corrective actions, etc. + Responsible for… more
- Medtronic (Fridley, MN)
- …Responsibilities may include the following and other duties may be assigned. + Lead investigations into fielded product issues including performing the risk ... for processes such as: Non conformances, Anomaly Dispositions, Deviations, Complaint Formal Investigations , Change Control and CAPA among others. **Must Have… more
- BeiGene (Hopewell, NJ)
- …and support. based in New Jersey (Hopewell), this role will be to lead the Hopewell drug product MST function to support technology transfer, validation, continued ... process verification, investigations , change management and site startup of Hopewell internal...**Leadership:** + Serve as MST DP SME and process lead for drug product, ensuring the materials, strategy and… more