- Repligen (Waltham, MA)
- …technical inquiries regarding OPUS® performance and applicationsPerform data driven investigations and resolve customer complaints in collaboration with Quality, ... Engineering and OperationsProvide technical troubleshooting support during customer qualification, validation and manufacturing runsApplication and Analytical ExpertiseProvide application expertise to internal teams on topics such as column performance, resin… more
- Tris Pharma (Monmouth Junction, NJ)
- …analysis and reporting; Administers and tracks SOPs, change controls, deviations, investigations , Corrective Action Preventive Action (CAPAs), and CPIs assigned to ... the Supply Chain department; Assists, tracks and reports key performance indicators (KPIs) to support continuous improvementRequirementsREQUIREMENTS Bachelors degree in Business, Supply Chain Management or related field Ability to quickly learn and understand… more
- Cipla (Central Islip, NY)
- …support packaging operations. Support the technical writing and Packaging investigations , Corrective Action Preventive Actions (CAPAs), change controls and ... validation activities as required. Apply complete knowledge of process improvement strategies and lean techniques (eg Method analysis, work combination charts, ergonomics, visual controls, safety, 5S,Fishbone Diagram, Kanban, poka yoke) to analyze and improve… more
- Cipla (Hauppauge, NY)
- …areas. Actively participating in review of data related to laboratory investigations and incidents and ensuring proper compliance. Performing other departmental and ... cross-functional projects and assignments given by the manager/supervisor. Education and Experience Possess a minimum bachelor's degree in chemistry, Pharmaceutical Sciences, or related field of study from an accredited institution. Master's degree in the… more
- Cipla (Central Islip, NY)
- …keep upper-level management informed of progress, Act as QA reviewer for investigations , deviations and CAPAs appropriate and designated by QA Management. Performs ... duties under limited supervision and according to standard operating and manufacturing procedures. Collaborates within Manufacturing to resolve document discrepancies or errors as it relates to Good Documentation Practices. Perform tasks in a manner consistent… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …HR processes as assigned Provide employee relations support by conducting investigations and providing appropriate guidance to drive manager consistency and ... compliance in handling performance management Provide support for individual development plan execution and assessing & establishing plan of action in relation to employee opinion survey results Participation in candidate selection, exit interviews & turnover… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to reduce non-conformances in supported areas by proactively driving compliance.Support Investigations team by providing quality and compliance input for continuous ... improvement and remediations.Serve as a backup for approving printed labels and documents prior to use on the manufacturing floor.Utilize multiple electronic quality systems, batch records and SAP.Work in a team based, cross-functional environment to complete… more
- Syner-G BioPharma Group (Boston, MA)
- …and/or revalidation/verification/commissioning activities.Write procedures, investigations , protocols, reports, change controls, ... etc., to support the Maintenance and Engineering departments.Perform P&ID Walkdowns. Perform Thermal mapping of temperature-controlled chambers, warehouses, and SIP processes.Support the resolution of regulatory observations or manufacturing site… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …contractors/vendors to complete tasksSupports and/or owns technical and quality investigations , CAPAs and correctionsDevelops and performs any required remediation ... efforts and associated CAPA plansAuthors, owns and executes master and completed CQV protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria, specifically data… more
- AUROBINDO (Dayton, OH)
- …laboratory instruments/equipments with supervisory direction/training.7. Perform troubleshooting and investigations under the direction of a supervisor.8. Comply ... with all regulatory/in-house requirements (may include but not limited to safety, house keeping, laboratory chemical waste, cGMP, cGLP, documentation) when performing the assigned activity.9. Review of Analytical documents as requiredQualifications - Skills &… more
