- Pfizer (New York, NY)
- **ROLE SUMMARY:** The Issue Lead will be responsible for driving Quality Event (QE) case management, ensuring that investigations are conducted thoroughly ... efficiency of the process by which Pfizer conducts GCP investigations , and leveraging data to assess the efficiency /...the appropriate teams to perform interventions as needed. The Issue Lead will also triage submitted cases… more
- Abbott (Columbus, OH)
- …and AMR Metrics. Additionally, they must work closely with cross-functional personnel to lead or support failure investigations and collaborate with other plant ... within this role include: (1) event management and responsibilities for the Abbott CAPA system, (2) project management as it relates to new product launches, trials,… 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
- 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
- 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
- Abbott (Westbrook, ME)
- …of end-user needs, design control outputs, on-market surveillance activities, and CAPA investigations . **Required Qualifications** + Bachelor's Degree in a ... management tools to prioritize activities and justify effort levels. + **Quality Issue Resolution:** Take decisive action to resolve quality issues by providing… more
- Mallinckrodt Pharmaceuticals (Hobart, NY)
- …takes appropriate action to correct any identified issues. Performs and leads investigations of product quality related events to determine scope of impact, ... corrective actions and rationale to support product disposition. Lead and assist with production safety, compliance and improvement initiatives as required. This is… 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)
- …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
- Merck (West Point, PA)
- …process validation, sterilization and cleaning validation, change implementation, deviation investigations and CAPA implementation among other related duties. ... customer needs to identify solutions. Approves technical documentation including investigations , protocols, qualification, validation etc. as required. Responsible for… 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
- Actalent (St. Louis, MO)
- …analyze error rates, identify root causes, and generate solutions. They will lead and drive implementation, validate new equipment, and work cross-functionally to ... systems, SOPs, work instructions, and test protocols. + Support root cause investigations and corrective actions regarding quality issues. + Champion the upkeep and… 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
- Sanofi Group (Framingham, MA)
- …of contractors for staff augmentation or project roles. + Ensuring timely issue escalation to senior management and cross-functional support teams + Partnering with ... support for end users. + Provide periodic 24x7 on-call rotation support. + Lead trainings, data migration activities, and provide system governance. + Develop and… more
- Takeda Pharmaceuticals (Thousand Oaks, CA)
- …with closure of observations/audit items. + Be a team member and help with CAPA Investigations for issues within respective area. + Apply problem solving tools ... related to product batch disposition to ensure adherence to lead times. **How you will contribute:** + Responsible for...Deviation. + Administer and maintain relevant databases, prepare, and issue reports defined by the area, and develop custom… more
- ManpowerGroup (Elkton, VA)
- …be required post selection.** + **50/50 floor/desk work.** + **Mixture of doing investigations , floor support, desk work Tech Ops group** + **Soft skills- Not afraid ... the box** + **Heavily Preferred- Relevant Co-ops and/or manufacturing experience. Capa , deviation, technical writing, change control all nice to have.**… more
- LSI Solutions (Victor, NY)
- …+ Lead and/or participate on Corrective Action and Preventive Action ( CAPA ) investigations . + Work independently as a self-starter with minimal direction. ... analysis, and develop, monitor, and oversee metrics reporting. + Lead and/or support activities for the development of the...+ Qualify new suppliers through the PPAP process. + Issue and implement SCAR's (Supplier Corrective Action Reports). +… more